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- Recall Enforcement Event ID: 74057
Recall Enforment Report D-1369-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmedium Services, LLC, originally initiated on 05-05-2016 for the product 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95 The product was recalled due to presence of particulate matter: api contaminated with glass particulate was used to produce sterile injectable drugs.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1369-2016 | 05-05-2016 | 07-27-2016 | Class II | 140 bags | 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1368-2016 | 05-05-2016 | 07-27-2016 | Class II | 2,874 bags | 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1384-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,577 BD syringes | 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1379-2016 | 05-05-2016 | 07-27-2016 | Class II | 750 bags | 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1371-2016 | 05-05-2016 | 07-27-2016 | Class II | 325 Medical Cassettes | 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1380-2016 | 05-05-2016 | 07-27-2016 | Class II | N/A | 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1391-2016 | 05-05-2016 | 07-27-2016 | Class II | 17,990 bags | 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1430-2016 | 05-05-2016 | 07-27-2016 | Class II | 90 bags | 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1392-2016 | 05-05-2016 | 07-27-2016 | Class II | 950 bags | 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1374-2016 | 05-05-2016 | 07-27-2016 | Class II | 361 bags | 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1372-2016 | 05-05-2016 | 07-27-2016 | Class II | 866 bags | 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1407-2016 | 05-05-2016 | 07-27-2016 | Class II | 380 bags | 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1376-2016 | 05-05-2016 | 07-27-2016 | Class II | 25 bags | 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1423-2016 | 05-05-2016 | 07-27-2016 | Class II | 3,474 bags | 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1367-2016 | 05-05-2016 | 07-27-2016 | Class II | 355 bags | 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ; | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1412-2016 | 05-05-2016 | 07-27-2016 | Class II | 555 Medical Cassettes | 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1364-2016 | 05-05-2016 | 07-27-2016 | Class II | 4,081 bags | 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1363-2016 | 05-05-2016 | 07-27-2016 | Class II | 15 bags | 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1414-2016 | 05-05-2016 | 07-27-2016 | Class II | 345 bags | 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1415-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,470 bags | 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1396-2016 | 05-05-2016 | 07-27-2016 | Class II | 97,716 bags | 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1429-2016 | 05-05-2016 | 07-27-2016 | Class II | 445 bags | 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1403-2016 | 05-05-2016 | 07-27-2016 | Class II | 105 bags | 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1378-2016 | 05-05-2016 | 07-27-2016 | Class II | 65 bags | 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1420-2016 | 05-05-2016 | 07-27-2016 | Class II | 936 Medical Cassettes | 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1375-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,527 bags | 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1426-2016 | 05-05-2016 | 07-27-2016 | Class II | 3,927 syringes | 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1395-2016 | 05-05-2016 | 07-27-2016 | Class II | 43,589 bags | 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1419-2016 | 05-05-2016 | 07-27-2016 | Class II | 3,828 syringes | 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1402-2016 | 05-05-2016 | 07-27-2016 | Class II | 95 bags | 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1399-2016 | 05-05-2016 | 07-27-2016 | Class II | 21 Medical Cassettes | 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-229-97 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1422-2016 | 05-05-2016 | 07-27-2016 | Class II | 655 bags | 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1383-2016 | 05-05-2016 | 07-27-2016 | Class II | 55 bags | 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1400-2016 | 05-05-2016 | 07-27-2016 | Class II | 480 bags | 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1401-2016 | 05-05-2016 | 07-27-2016 | Class II | 90 bags | 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1425-206 | 05-05-2016 | 07-27-2016 | Class II | 2,713 syringes | 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1411-2016 | 05-05-2016 | 07-27-2016 | Class II | 212 Medical Cassettes | 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1389-2016 | 05-05-2016 | 07-27-2016 | Class II | 425 bags | 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1409-2016 | 05-05-2016 | 07-27-2016 | Class II | 435 Monoject Syringes | 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1360-2016 | 05-05-2016 | 07-27-2016 | Class II | 177 Medical Cassettes | 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1365-2016 | 05-05-2016 | 07-27-2016 | Class II | 8,581 bags | 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1366-2016 | 05-05-2016 | 07-27-2016 | Class II | 315 Medical Cassettes | 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1381-2016 | 05-05-2016 | 07-27-2016 | Class II | 600 Monoject Syringes | 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1390-2016 | 05-05-2016 | 07-27-2016 | Class II | 60 bags | 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1416-2016 | 05-05-2016 | 07-27-2016 | Class II | 5,727 Medical Cassettes | 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1424-2016 | 05-05-2016 | 07-27-2016 | Class II | 562 bags | 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1370-2016 | 05-05-2016 | 07-27-2016 | Class II | 10 bags | 0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1434-2016 | 05-05-2016 | 07-27-2016 | Class II | 650 bags | 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1377-2016 | 05-05-2016 | 07-27-2016 | Class II | 384 Medical Cassettes | 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1406-2016 | 05-05-2016 | 07-27-2016 | Class II | 220 Medical Cassettes | 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1428-2016 | 05-05-2016 | 07-27-2016 | Class II | 115 bags | 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1398-2016 | 05-05-2016 | 07-27-2016 | Class II | 940 bags | 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1433-2016 | 05-05-2016 | 07-27-2016 | Class II | 79 syringes | 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1431-2016 | 05-05-2016 | 07-27-2016 | Class II | 5 syringes | 5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1382-2016 | 05-05-2016 | 07-27-2016 | Class II | 740 BD syringes | 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1417-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,015 bags | 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1373-2016 | 05-05-2016 | 07-27-2016 | Class II | 40 Medical Cassettes | 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1393-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,476 bags | 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1394-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,280 Medical Cassettes | 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1405-2016 | 05-05-2016 | 07-27-2016 | Class II | 2,006 bags | 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1387-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,277 bags | 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1432-2016 | 05-05-2016 | 07-27-2016 | Class II | 180 syringes | 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1386-2016 | 05-05-2016 | 07-27-2016 | Class II | 1,234 Medical Cassettes | 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1361-2016 | 05-05-2016 | 07-27-2016 | Class II | 80 bags | 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 , | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1413-2016 | 05-05-2016 | 07-27-2016 | Class II | 700 bags | 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1427-2016 | 05-05-2016 | 07-27-2016 | Class II | 45 Medical Cassettes | 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1397-2016 | 05-05-2016 | 07-27-2016 | Class II | 250 bags | 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1418-2016 | 05-05-2016 | 07-27-2016 | Class II | 455 bags | 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1385-2016 | 05-05-2016 | 07-27-2016 | Class II | 30 bags | 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1421-2016 | 05-05-2016 | 07-27-2016 | Class II | 2,256 Medical Cassettes | 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1408-2016 | 05-05-2016 | 07-27-2016 | Class II | 10 bags | 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1388-2016 | 05-05-2016 | 07-27-2016 | Class II | 230 BD syringes | 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1362-2016 | 05-05-2016 | 07-27-2016 | Class II | 2,194 bags and cassettes | 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ; | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1404-2016 | 05-05-2016 | 07-27-2016 | Class II | 85 Medical Cassettes | 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
| D-1410-2016 | 05-05-2016 | 07-27-2016 | Class II | 25 bags | 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated |
Recall Enforcement Report D-1369-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1369-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 140 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number: 160970109M, Exp. Date 5/7/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1368-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1368-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,874 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 ; Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 ; Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 ; Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 ; Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 ; Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 ; Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 ; Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 ; Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 ; Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 ; Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 ; Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 ; Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 ; Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 ; Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 ; Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 ; Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 ; Service Code 2K8120 , Lot Number 160940060M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 160410183M , Exp. Date 5/11/2016 ; Service Code 2K8243 , Lot Number 160420152M , Exp. Date 5/12/2016 ; Service Code 2K8243 , Lot Number 160460131M , Exp. Date 5/16/2016 ; Service Code 2K8243 , Lot Number 160490239M , Exp. Date 5/19/2016 ; Service Code 2K8243 , Lot Number 160520184M , Exp. Date 5/22/2016 ; Service Code 2K8243 , Lot Number 160550125M , Exp. Date 5/25/2016 ; Service Code 2K8243 , Lot Number 160590160M , Exp. Date 5/29/2016 ; Service Code 2K8243 , Lot Number 160600171M , Exp. Date 5/30/2016 ; Service Code 2K8243 , Lot Number 160610227M , Exp. Date 5/31/2016 ; Service Code 2K8243 , Lot Number 160620142M , Exp. Date 6/1/2016 ; Service Code 2K8243 , Lot Number 160630199M , Exp. Date 6/2/2016 ; Service Code 2K8243 , Lot Number 160660168M , Exp. Date 6/5/2016 ; Service Code 2K8243 , Lot Number 160670236M , Exp. Date 6/6/2016 ; Service Code 2K8243 , Lot Number 160700192M , Exp. Date 6/9/2016 ; Service Code 2K8243 , Lot Number 160740235M , Exp. Date 6/13/2016 ; Service Code 2K8243 , Lot Number 160760190M , Exp. Date 6/15/2016 ; Service Code 2K8243 , Lot Number 160810280M , Exp. Date 6/20/2016 ; Service Code 2K8243 , Lot Number 160820234M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160830120M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160870168M , Exp. Date 6/26/2016 ; Service Code 2K8243 , Lot Number 160900173M , Exp. Date 6/29/2016 ; Service Code 2K8243 , Lot Number 160910176M , Exp. Date 6/30/2016 ; Service Code 2K8243 , Lot Number 160940041M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 161080168M , Exp. Date 7/17/2016 ; Service Code 2K9120 , Lot Number 160380034C , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160380105M , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160420030C , Exp. Date 5/12/2016 ; Service Code 2K9120 , Lot Number 160470039C , Exp. Date 5/17/2016 ; Service Code 2K9120 , Lot Number 160540034C , Exp. Date 5/24/2016 ; Service Code 2K9120 , Lot Number 160550029C , Exp. Date 5/25/2016 ; Service Code 2K9120 , Lot Number 160590078M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160600067M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160670187M , Exp. Date 6/6/2016 ; Service Code 2K9120 , Lot Number 160730076M , Exp. Date 6/11/2016 ; Service Code 2K9120 , Lot Number 160750233M , Exp. Date 6/14/2016 ; Service Code 2K9120 , Lot Number 160770001M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160770049M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160810056M , Exp. Date 6/19/2016 ; Service Code 2K9120 , Lot Number 160870069M , Exp. Date 6/26/2016 ; Service Code 2K9120 , Lot Number 160910184M , Exp. Date 6/30/2016 ; Service Code 2K9120 , Lot Number 160940154M , Exp. Date 7/3/2016 ; Service Code 2K9120 , Lot Number 160960190M , Exp. Date 7/5/2016 ; Service Code 2K9120 , Lot Number 161080156M , Exp. Date 7/17/2016 ; Service Code 2N1120 , Lot Number 160960241M , Exp. Date 7/5/2016 ; Service Code 2N9619 , Lot Number 160950229M , Exp. Date 7/4/2016 ; Service Code 2R3317-5 , Lot Number 160420122M , Exp. Date 5/12/2016 ; Service Code 2R3317-5 , Lot Number 160550206M , Exp. Date 5/24/2016 ; Service Code 2R3317-5 , Lot Number 160590164M , Exp. Date 5/29/2016 ; Service Code 2R3317-5 , Lot Number 160660159M , Exp. Date 6/5/2016 ; Service Code 2R3317-5 , Lot Number 160690151M , Exp. Date 6/7/2016 ; Service Code 2R3317-5 , Lot Number 160740252M , Exp. Date 6/13/2016 ; Service Code 2R3317-5 , Lot Number 160750181M , Exp. Date 6/14/2016 ; Service Code 2R3317-5 , Lot Number 160810298M , Exp. Date 6/20/2016 ; Service Code 2R3317-5 , Lot Number 160830222M , Exp. Date 6/22/2016 ; Service Code 2R3317-5 , Lot Number 160940150M , Exp. Date 7/3/2016 ; Service Code 2R3317-5 , Lot Number 161080209M , Exp. Date 7/17/2016 ; Service Code 3317NO , Lot Number 160380157M , Exp. Date 5/8/2016 ; Service Code 3317NO , Lot Number 160420173M , Exp. Date 5/11/2016 ; Service Code 3317NO , Lot Number 160540140M , Exp. Date 5/24/2016 ; Service Code 3317NO , Lot Number 160600185M , Exp. Date 5/30/2016 ; Service Code 3317NO , Lot Number 160630204M , Exp. Date 6/2/2016 ; Service Code 3317NO , Lot Number 160660172M , Exp. Date 6/5/2016 ; Service Code 3317NO , Lot Number 160700219M , Exp. Date 6/9/2016 ; Service Code 3317NO , Lot Number 160770174M , Exp. Date 6/16/2016 ; Service Code 3317NO , Lot Number 160840205M , Exp. Date 6/23/2016 ; Service Code 3317NO , Lot Number 160910210M , Exp. Date 6/30/2016 ; Service Code 3317NO , Lot Number 161080215M , Exp. Date 7/17/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1384-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1384-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,577 BD syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2T6733 , Lot Number 160560088M , Exp. Date 5/25/2016 ; Service Code 2T6733 , Lot Number 160590097M , Exp. Date 5/28/2016 ; Service Code 2T6733 , Lot Number 160610032M , Exp. Date 5/31/2016 ; Service Code 2T6733 , Lot Number 160630191M , Exp. Date 6/2/2016 ; Service Code 2T6733 , Lot Number 160740251M , Exp. Date 6/13/2016 ; Service Code 2T6733 , Lot Number 160890051M , Exp. Date 6/27/2016 ; Service Code 2T6733 , Lot Number 160910161M , Exp. Date 6/29/2016 ; Service Code 2K8478 , Lot Number 160380039M , Exp. Date 5/8/2016 ; Service Code 2K8478 , Lot Number 160410139M , Exp. Date 5/11/2016 ; Service Code 2K8478 , Lot Number 160450247M , Exp. Date 5/15/2016 ; Service Code 2K8478 , Lot Number 160540145M , Exp. Date 5/24/2016 ; Service Code 2K8478 , Lot Number 160610157M , Exp. Date 5/31/2016 ; Service Code 2K8478 , Lot Number 160660142M , Exp. Date 6/5/2016 ; Service Code 2K8478 , Lot Number 160730262M , Exp. Date 6/12/2016 ; Service Code 2K8478 , Lot Number 160770247M , Exp. Date 6/16/2016 ; Service Code 2K8478 , Lot Number 160810195M , Exp. Date 6/20/2016 ; Service Code 2K8478 , Lot Number 160890161M , Exp. Date 6/28/2016 ; Service Code 2K8478 , Lot Number 160910234M , Exp. Date 6/30/2016 ; Service Code 2K8478 , Lot Number 160940235M , Exp. Date 7/3/2016 ; Service Code 2T8478 , Lot Number 160910132M , Exp. Date 5/7/2016 ; Service Code 2T8478 , Lot Number 160940032C , Exp. Date 5/10/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1379-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1379-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 750 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , Exp. Date 6/2/2016 ; Lot Number 160740027C , Exp. Date 6/9/2016 ; Lot Number 160810024C , Exp. Date 6/16/2016 ; Lot Number 160880005C , Exp. Date 6/23/2016 ; Lot Number 160950036M , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1371-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1371-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 325 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160960175M; Exp. Date 5/6/2016 Lot Number 160970036M; Exp. Date 5/7/2016 Lot Number 161080071M; Exp. Date 5/18/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1380-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1380-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1391-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1391-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 17,990 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 160880271M , Exp. Date 6/27/2016 ; Service Code 2H8129 , Lot Number 160540238M , Exp. Date 5/20/2016 ; Service Code 2H8129 , Lot Number 160590104M , Exp. Date 5/25/2016 ; Service Code 2H8129 , Lot Number 160660247M , Exp. Date 6/1/2016 ; Service Code 2H8129 , Lot Number 160730274M , Exp. Date 6/8/2016 ; Service Code 2H8129 , Lot Number 160810226M , Exp. Date 6/16/2016 ; Service Code 2H8129 , Lot Number 160840032M , Exp. Date 6/19/2016 ; Service Code 2H8129 , Lot Number 160940173M , Exp. Date 6/29/2016 ; Service Code 2H8129 , Lot Number 161080115M , Exp. Date 7/13/2016 ; Service Code 2H8132 , Lot Number 160390248M , Exp. Date 5/9/2016 ; Service Code 2H8132 , Lot Number 160460217M , Exp. Date 5/16/2016 ; Service Code 2H8132 , Lot Number 160490227M , Exp. Date 5/19/2016 ; Service Code 2H8132 , Lot Number 160530175M , Exp. Date 5/23/2016 ; Service Code 2H8132 , Lot Number 160600229M , Exp. Date 5/30/2016 ; Service Code 2H8132 , Lot Number 160660244M , Exp. Date 6/5/2016 ; Service Code 2H8132 , Lot Number 160700169M , Exp. Date 6/9/2016 ; Service Code 2H8132 , Lot Number 160750149M , Exp. Date 6/14/2016 ; Service Code 2H8132 , Lot Number 160830147M , Exp. Date 6/22/2016 ; Service Code 2H8132 , Lot Number 160890269M , Exp. Date 6/28/2016 ; Service Code 2H8132 , Lot Number 160940240M , Exp. Date 7/3/2016 ; Service Code 2K8121 , Lot Number 160380131M , Exp. Date 5/8/2016 ; Service Code 2K8121 , Lot Number 160410135M , Exp. Date 5/11/2016 ; Service Code 2K8121 , Lot Number 160490155M , Exp. Date 5/19/2016 ; Service Code 2K8121 , Lot Number 160550154M , Exp. Date 5/25/2016 ; Service Code 2K8121 , Lot Number 160600215M , Exp. Date 5/30/2016 ; Service Code 2K8121 , Lot Number 160660234M , Exp. Date 6/5/2016 ; Service Code 2K8121 , Lot Number 160730257M , Exp. Date 6/12/2016 ; Service Code 2K8121 , Lot Number 160800137M , Exp. Date 6/19/2016 ; Service Code 2K8121 , Lot Number 160830143M , Exp. Date 6/22/2016 ; Service Code 2K8121 , Lot Number 160910135M , Exp. Date 6/30/2016 ; Service Code 2K8121 , Lot Number 160940233M , Exp. Date 7/3/2016 ; Service Code 2K8132 , Lot Number 160420102M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420214M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420342M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160450074M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450075M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450364M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160470314M , Exp. Date 5/11/2016 ; Service Code 2K8132 , Lot Number 160480039M , Exp. Date 5/12/2016 ; Service Code 2K8132 , Lot Number 160520295M , Exp. Date 5/16/2016 ; Service Code 2K8132 , Lot Number 160530061M , Exp. Date 5/17/2016 ; Service Code 2K8132 , Lot Number 160550332M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160550333M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160590128M , Exp. Date 5/23/2016 ; Service Code 2K8132 , Lot Number 160610345M , Exp. Date 5/25/2016 ; Service Code 2K8132 , Lot Number 160620323M , Exp. Date 5/26/2016 ; Service Code 2K8132 , Lot Number 160630049M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160630311M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160660105M , Exp. Date 5/30/2016 ; Service Code 2K8132 , Lot Number 160670059M , Exp. Date 5/31/2016 ; Service Code 2K8132 , Lot Number 160680062M , Exp. Date 6/1/2016 ; Service Code 2K8132 , Lot Number 160690053M , Exp. Date 6/2/2016 ; Service Code 2K8132 , Lot Number 160700311M , Exp. Date 6/3/2016 ; Service Code 2K8132 , Lot Number 160730118M , Exp. Date 6/6/2016 ; Service Code 2K8132 , Lot Number 160750058M , Exp. Date 6/8/2016 ; Service Code 2K8132 , Lot Number 160760291M , Exp. Date 6/9/2016 ; Service Code 2K8132 , Lot Number 160770324M , Exp. Date 6/10/2016 ; Service Code 2K8132 , Lot Number 160800122M , Exp. Date 6/13/2016 ; Service Code 2K8132 , Lot Number 160810238M , Exp. Date 6/14/2016 ; Service Code 2K8132 , Lot Number 160820044M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820079M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820080M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160830059M , Exp. Date 6/16/2016 ; Service Code 2K8132 , Lot Number 160870117M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160870336M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160880064M , Exp. Date 6/21/2016 ; Service Code 2K8132 , Lot Number 160890069M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890367M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890368M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160900057M , Exp. Date 6/23/2016 ; Service Code 2K8132 , Lot Number 160910324M , Exp. Date 6/24/2016 ; Service Code 2K8132 , Lot Number 160950330M , Exp. Date 6/28/2016 ; Service Code 2K8132 , Lot Number 160960326M , Exp. Date 6/29/2016 ; Service Code 2K8132 , Lot Number 160970297M , Exp. Date 6/30/2016 ; Service Code 2K8132 , Lot Number 161090001M , Exp. Date 7/11/2016 ; Service Code 2K8639 , Lot Number 160420251M , Exp. Date 5/12/2016 ; Service Code 2K8639 , Lot Number 160490106M , Exp. Date 5/18/2016 ; Service Code 2K8639 , Lot Number 160550111M , Exp. Date 5/24/2016 ; Service Code 2K8639 , Lot Number 160600305M , Exp. Date 5/30/2016 ; Service Code 2K8639 , Lot Number 160730255M , Exp. Date 6/12/2016 ; Service Code 2K8639 , Lot Number 160800207M , Exp. Date 6/19/2016 ; Service Code 2K8639 , Lot Number 160830196M , Exp. Date 6/22/2016 ; Service Code 2K8639 , Lot Number 160900151M , Exp. Date 6/29/2016 ; Service Code 2K8639 , Lot Number 161080236M , Exp. Date 7/17/2016 ; Service Code 2K8862 , Lot Number 160610069M , Exp. Date 5/21/2016 ; Service Code 2K8862 , Lot Number 160630040M , Exp. Date 5/23/2016 ; Service Code 2K8862 , Lot Number 160670182M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160680046M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160800056M , Exp. Date 6/9/2016 ; Service Code 2K8862 , Lot Number 160840030M , Exp. Date 6/13/2016 ; Service Code 2K8862 , Lot Number 160840126M , Exp. Date 6/14/2016 ; Service Code 2K8862 , Lot Number 160870048M , Exp. Date 6/16/2016 ; Service Code 2K8862 , Lot Number 160940149M , Exp. Date 6/24/2016 ; Service Code 2K8862 , Lot Number 160950029C , Exp. Date 6/25/2016 ; Service Code 2K8862 , Lot Number 160960240M , Exp. Date 6/26/2016 ; Service Code 2K8966 , Lot Number 160830024C , Exp. Date 6/13/2016 ; Service Code 2K9121 , Lot Number 160460255M , Exp. Date 5/16/2016 ; Service Code 2K9121 , Lot Number 160600258M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600259M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600260M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160750165M , Exp. Date 6/14/2016 ; Service Code 2K9121 , Lot Number 160750166M , Exp. Date 6/14/2016 ; Service Code 2K9132 , Lot Number 160450014C , Exp. Date 5/9/2016 ; Service Code 2K9132 , Lot Number 160520015C , Exp. Date 5/16/2016 ; Service Code 2K9132 , Lot Number 160600001C , Exp. Date 5/23/2016 ; Service Code 2K9132 , Lot Number 160670015C , Exp. Date 5/31/2016 ; Service Code 2K9132 , Lot Number 160730005C , Exp. Date 6/6/2016 ; Service Code 2K9132 , Lot Number 160800021C , Exp. Date 6/13/2016 ; Service Code 2K9132 , Lot Number 160870006C , Exp. Date 6/20/2016 ; Service Code 2K9132 , Lot Number 160940120M , Exp. Date 6/27/2016 ; Service Code 2K9132 , Lot Number 161080116M , Exp. Date 7/11/2016 ; Service Code 2T8862 , Lot Number 160960238M , Exp. Date 5/6/2016 ; Service Code 2T8862 , Lot Number 160970116M , Exp. Date 5/6/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1430-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1430-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 90 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160730064M , Exp. Date 6/2/2016 ; Lot Number 160800057M , Exp. Date 6/9/2016 ; Lot Number 160820113M , Exp. Date 6/11/2016 ; Lot Number 160960142M , Exp. Date 6/26/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1392-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1392-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 950 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1374-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1374-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 361 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160460204M , Exp. Date 5/10/2016 ; Lot Number 160560170M , Exp. Date 5/20/2016 ; Lot Number 160700007M , Exp. Date 6/2/2016 ; Lot Number 160810176M , Exp. Date 6/14/2016 ; Lot Number 160830325M , Exp. Date 6/16/2016 ; Lot Number 160880270M , Exp. Date 6/21/2016 ; Lot Number 160890245M , Exp. Date 6/22/2016 ; Lot Number 160900144M , Exp. Date 6/23/2016 ; Lot Number 160950241M , Exp. Date 6/28/2016 ; Lot Number 161080135M , Exp. Date 7/11/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1372-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1372-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 866 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , Exp. Date 7/4/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1407-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1407-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 380 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160530277M , Exp. Date 5/17/2016 ; Lot Number 160610199M , Exp. Date 5/25/2016 ; Lot Number 160660176M , Exp. Date 5/30/2016 ; Lot Number 160690200M , Exp. Date 6/2/2016 ; Lot Number 160770187M , Exp. Date 6/10/2016 ; Lot Number 160890268M , Exp. Date 6/22/2016 ; Lot Number 160960227M , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1376-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1376-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 25 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot # 160970162M; Exp. Date 5/7/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1423-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1423-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,474 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 ; Service Code 2H8136 , Lot Number 160400231M , Exp. Date 5/10/2016 ; Service Code 2H8136 , Lot Number 160410114M , Exp. Date 5/11/2016 ; Service Code 2H8136 , Lot Number 160460187M , Exp. Date 5/16/2016 ; Service Code 2H8136 , Lot Number 160490237M , Exp. Date 5/19/2016 ; Service Code 2H8136 , Lot Number 160520172M , Exp. Date 5/22/2016 ; Service Code 2H8136 , Lot Number 160530288M , Exp. Date 5/23/2016 ; Service Code 2H8136 , Lot Number 160600186M , Exp. Date 5/30/2016 ; Service Code 2H8136 , Lot Number 160630207M , Exp. Date 6/2/2016 ; Service Code 2H8136 , Lot Number 160670243M , Exp. Date 6/6/2016 ; Service Code 2H8136 , Lot Number 160730070M , Exp. Date 6/11/2016 ; Service Code 2H8136 , Lot Number 160740213M , Exp. Date 6/13/2016 ; Service Code 2H8136 , Lot Number 160810151M , Exp. Date 6/20/2016 ; Service Code 2H8136 , Lot Number 160830114M , Exp. Date 6/22/2016 ; Service Code 2H8136 , Lot Number 160880266M , Exp. Date 6/27/2016 ; Service Code 2H8136 , Lot Number 160950223M , Exp. Date 7/4/2016 ; Service Code 2H8136 , Lot Number 160960179M , Exp. Date 7/5/2016 ; Service Code 2H8136 , Lot Number 161080119M , Exp. Date 7/17/2016 ; Service Code 2K8135 , Lot Number 160390318M , Exp. Date 5/9/2016 ; Service Code 2K8135 , Lot Number 160450256M , Exp. Date 5/15/2016 ; Service Code 2K8135 , Lot Number 160520144M , Exp. Date 5/22/2016 ; Service Code 2K8135 , Lot Number 160660248M , Exp. Date 6/5/2016 ; Service Code 2K8135 , Lot Number 160730089M , Exp. Date 6/12/2016 ; Service Code 2K8135 , Lot Number 160840235M , Exp. Date 6/23/2016 ; Service Code 2K8135 , Lot Number 160950175M , Exp. Date 7/4/2016 ; Service Code 2K8136 , Lot Number 160470209M , Exp. Date 5/11/2016 ; Service Code 2K8136 , Lot Number 160490159M , Exp. Date 5/13/2016 ; Service Code 2K8136 , Lot Number 160560128M , Exp. Date 5/20/2016 ; Service Code 2K8136 , Lot Number 160600250M , Exp. Date 5/24/2016 ; Service Code 2K8136 , Lot Number 160660268M , Exp. Date 5/30/2016 ; Service Code 2K8136 , Lot Number 160730128M , Exp. Date 6/6/2016 ; Service Code 2K8136 , Lot Number 160770110M , Exp. Date 6/10/2016 ; Service Code 2K8136 , Lot Number 160810309M , Exp. Date 6/14/2016 ; Service Code 2K8136 , Lot Number 160840046M , Exp. Date 6/17/2016 ; Service Code 2K8136 , Lot Number 160890166M , Exp. Date 6/22/2016 ; Service Code 2K8136 , Lot Number 160970110M , Exp. Date 6/30/2016 ; Service Code 2K8136 , Lot Number 161080316M , Exp. Date 7/11/2016 ; Service Code 2K8447 , Lot Number 160480124M , Exp. Date 5/12/2016 ; Service Code 2K8447 , Lot Number 160560102M , Exp. Date 5/19/2016 ; Service Code 2K8447 , Lot Number 160620043M , Exp. Date 5/25/2016 ; Service Code 2K8447 , Lot Number 160820219M , Exp. Date 6/15/2016 ; Service Code 2K8945 , Lot Number 160460179M , Exp. Date 5/6/2016 ; Service Code 2K8945 , Lot Number 160680052M , Exp. Date 5/28/2016 ; Service Code 2K8945 , Lot Number 160890253M , Exp. Date 6/19/2016 ; Service Code 2K8984 , Lot Number 160490124M , Exp. Date 5/9/2016 ; Service Code 2K8984 , Lot Number 160530219M , Exp. Date 5/14/2016 ; Service Code 2K8984 , Lot Number 160550193M , Exp. Date 5/15/2016 ; Service Code 2K8984 , Lot Number 160620141M , Exp. Date 5/23/2016 ; Service Code 2K8984 , Lot Number 160690159M , Exp. Date 5/30/2016 ; Service Code 2K8984 , Lot Number 160750189M , Exp. Date 6/5/2016 ; Service Code 2K8984 , Lot Number 160820117M , Exp. Date 6/11/2016 ; Service Code 2K8984 , Lot Number 161080172M , Exp. Date 7/8/2016 ; Service Code 2K9135 , Lot Number 160520112M , Exp. Date 5/16/2016 ; Service Code 2K9135 , Lot Number 160600209M , Exp. Date 5/24/2016 ; Service Code 2K9135 , Lot Number 160620189M , Exp. Date 5/26/2016 ; Service Code 2K9135 , Lot Number 160660051M , Exp. Date 5/29/2016 ; Service Code 2K9135 , Lot Number 160830126M , Exp. Date 6/15/2016 ; Service Code 2K9135 , Lot Number 160890180M , Exp. Date 6/22/2016 ; Service Code 2K9135 , Lot Number 160910126M , Exp. Date 6/24/2016 ; Service Code 2K9915 , Lot Number 160620026C , Exp. Date 5/26/2016 ; Service Code 2K9915 , Lot Number 160740050C , Exp. Date 6/7/2016 ; Service Code 2K9915 , Lot Number 160810059C , Exp. Date 6/15/2016 ; Service Code 2T6135 , Lot Number 160400229M , Exp. Date 5/10/2016 ; Service Code 2T6135 , Lot Number 160450178M , Exp. Date 5/15/2016 ; Service Code 2T6135 , Lot Number 160490241M , Exp. Date 5/19/2016 ; Service Code 2T6135 , Lot Number 160620220M , Exp. Date 6/1/2016 ; Service Code 2T6135 , Lot Number 160680050M , Exp. Date 6/6/2016 ; Service Code 2T6135 , Lot Number 160810281M , Exp. Date 6/20/2016 ; Service Code 2T6135 , Lot Number 160940052M , Exp. Date 7/2/2016 ; Service Code 2T6135 , Lot Number 160950068M , Exp. Date 7/4/2016 ; Service Code 4J8136 , Lot Number 160460142M , Exp. Date 5/10/2016 ; Service Code 4J8136 , Lot Number 160680034M , Exp. Date 5/31/2016 ; Service Code 4J8136 , Lot Number 160740033M , Exp. Date 6/6/2016 ; Service Code 4J8136 , Lot Number 160880020M , Exp. Date 6/20/2016 ; Service Code 4J8136 , Lot Number 160950048M , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1367-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1367-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 355 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 ; Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 ; Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 ; Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 ; Service Code 2K8463 , Lot Number 160400227M , Exp. Date 5/10/2016 ; Service Code 2K8463 , Lot Number 160630030M , Exp. Date 6/1/2016 ; Service Code 2K8463 , Lot Number 160890243M , Exp. Date 6/28/2016 ; Service Code 2K8463 , Lot Number 160970195M , Exp. Date 7/6/2016 ; Service Code 2K8931 , Lot Number 160970018C , Exp. Date 5/7/2016 ; Service Code 2N1119 , Lot Number 160490041C , Exp. Date 5/19/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1412-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1412-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 555 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016 ; Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016 ; Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016 ; Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016 ; Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016 ; Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016 ; Service Code 2K8913 , Lot Number 160940019C , Exp. Date 5/10/2016 ; Service Code 2K8913 , Lot Number 160960022C , Exp. Date 5/12/2016 ; Service Code 2K8913 , Lot Number 160970021C , Exp. Date 5/13/2016 ; Service Code 2K8947 , Lot Number 160970025C , Exp. Date 5/17/2016 ; Service Code 2K8986 , Lot Number 160910040M , Exp. Date 5/11/2016 ; Service Code 2T6622 , Lot Number 160950152M , Exp. Date 5/10/2016 ; Service Code 2K8495 , Lot Number 160520175M , Exp. Date 5/22/2016 ; Service Code 2K8495 , Lot Number 160530128M , Exp. Date 5/23/2016 ; Service Code 2K8495 , Lot Number 160540117M , Exp. Date 5/24/2016 ; Service Code 2K8495 , Lot Number 160550130M , Exp. Date 5/25/2016 ; Service Code 2K8495 , Lot Number 160560135M , Exp. Date 5/26/2016 ; Service Code 2K8495 , Lot Number 160610198M , Exp. Date 5/31/2016 ; Service Code 2K8495 , Lot Number 160740237M , Exp. Date 6/13/2016 ; Service Code 2K8495 , Lot Number 160750177M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160760001M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160820228M , Exp. Date 6/21/2016 ; Service Code 2K8495 , Lot Number 160890173M , Exp. Date 6/28/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1364-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1364-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4,081 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 ; Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 ; Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 ; Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 ; Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 ; Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 ; Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 ; Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 ; Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 ; Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 ; Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 ; Service Code 2H8266 , Lot Number 160740185M , Exp. Date 6/13/2016 ; Service Code 2H8266 , Lot Number 160830175M , Exp. Date 6/22/2016 ; Service Code 2H8266 , Lot Number 160950218M , Exp. Date 7/4/2016 ; Service Code 2H8272 , Lot Number 160450150M , Exp. Date 5/15/2016 ; Service Code 2H8272 , Lot Number 160600070M , Exp. Date 5/29/2016 ; Service Code 2H8272 , Lot Number 160900043M , Exp. Date 6/28/2016 ; Service Code 2K8115 , Lot Number 160530135M , Exp. Date 5/23/2016 ; Service Code 2K8115 , Lot Number 160740158M , Exp. Date 6/13/2016 ; Service Code 2K8115 , Lot Number 160940047M , Exp. Date 7/2/2016 ; Service Code 2K8115 , Lot Number 160950158M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 160390353M , Exp. Date 5/9/2016 ; Service Code 2K8216 , Lot Number 160470237M , Exp. Date 5/17/2016 ; Service Code 2K8216 , Lot Number 160480276M , Exp. Date 5/18/2016 ; Service Code 2K8216 , Lot Number 160540026M , Exp. Date 5/24/2016 ; Service Code 2K8216 , Lot Number 160610271M , Exp. Date 5/31/2016 ; Service Code 2K8216 , Lot Number 160730105M , Exp. Date 6/12/2016 ; Service Code 2K8216 , Lot Number 160820198M , Exp. Date 6/21/2016 ; Service Code 2K8216 , Lot Number 160890280M , Exp. Date 6/28/2016 ; Service Code 2K8216 , Lot Number 160950038M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 161080329M , Exp. Date 7/17/2016 ; Service Code 2K8265 , Lot Number 160390177M , Exp. Date 5/9/2016 ; Service Code 2K8265 , Lot Number 160460174M , Exp. Date 5/16/2016 ; Service Code 2K8265 , Lot Number 160670198M , Exp. Date 6/6/2016 ; Service Code 2K8265 , Lot Number 160700004M , Exp. Date 6/8/2016 ; Service Code 2K8941 , Lot Number 160660352M , Exp. Date 5/15/2016 ; Service Code 2K8941 , Lot Number 160670183M , Exp. Date 5/16/2016 ; Service Code 2K8941 , Lot Number 160680195M , Exp. Date 5/17/2016 ; Service Code 2K8941 , Lot Number 160700129M , Exp. Date 5/18/2016 ; Service Code 2K8941 , Lot Number 160810184M , Exp. Date 5/30/2016 ; Service Code 2K8941 , Lot Number 160880172M , Exp. Date 6/5/2016 ; Service Code 2K8941 , Lot Number 160950159M , Exp. Date 6/13/2016 ; Service Code 2K8981 , Lot Number 160810255M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160820101M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160870158M , Exp. Date 6/5/2016 ; Service Code 2K8981 , Lot Number 160940056M , Exp. Date 6/12/2016 ; Service Code 2K9195 , Lot Number 160480120M , Exp. Date 5/18/2016 ; Service Code 2K9195 , Lot Number 160560132M , Exp. Date 5/26/2016 ; Service Code 2K9195 , Lot Number 160630008M , Exp. Date 6/1/2016 ; Service Code 2K9195 , Lot Number 160690115M , Exp. Date 6/8/2016 ; Service Code 2K9195 , Lot Number 160800136M , Exp. Date 6/19/2016 ; Service Code 2K9195 , Lot Number 160960023M , Exp. Date 7/5/2016 ; Service Code 2N1216 , Lot Number 160410171M , Exp. Date 5/11/2016 ; Service Code 2N1216 , Lot Number 160460136M , Exp. Date 5/16/2016 ; Service Code 2N1216 , Lot Number 160550200M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160560092M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160590070M , Exp. Date 5/29/2016 ; Service Code 2N1216 , Lot Number 160820128M , Exp. Date 6/21/2016 ; Service Code 2N1216 , Lot Number 160870064M , Exp. Date 6/25/2016 ; Service Code 2N1216 , Lot Number 160910029M , Exp. Date 6/29/2016 ; Service Code 2N1216 , Lot Number 160940046M , Exp. Date 7/2/2016 ; Service Code 2T8929 , Lot Number 160380099M , Exp. Date 5/7/2016 ; Service Code 2T8929 , Lot Number 160450107M , Exp. Date 5/14/2016 ; Service Code 2T8929 , Lot Number 160520098M , Exp. Date 5/21/2016 ; Service Code 2T8929 , Lot Number 160670039C , Exp. Date 6/6/2016 ; Service Code 2T8929 , Lot Number 160730024C , Exp. Date 6/12/2016 ; Service Code 2T8929 , Lot Number 160870018C , Exp. Date 6/25/2016 ; Service Code 2T8981 , Lot Number 160380016C , Exp. Date 5/8/2016 ; Service Code 2T8981 , Lot Number 160450021C , Exp. Date 5/15/2016 ; Service Code 2T8981 , Lot Number 160590008C , Exp. Date 5/29/2016 ; Service Code 2T8981 , Lot Number 160800031C , Exp. Date 6/19/2016 ; Service Code 2T8981 , Lot Number 160870012C , Exp. Date 6/26/2016 ; Service Code 3V8716 , Lot Number 160480036C , Exp. Date 5/18/2016 ; Service Code 3V8716 , Lot Number 160680034C , Exp. Date 6/7/2016 ; Service Code 3V8716 , Lot Number 160810069C , Exp. Date 6/20/2016 ; Service Code 3V8716 , Lot Number 160820048C , Exp. Date 6/21/2016 ; Service Code 3V8716 , Lot Number 160950060C , Exp. Date 7/4/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1363-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1363-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 15 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number: 160700041M; Exp. Date 6/8/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1414-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1414-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 345 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 ; Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 ; Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 ; Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 ; Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 ; Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 ; Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 ; Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 ; Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 ; Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 ; Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 ; Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 ; Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 ; Service Code 2K8180 , Lot Number 160940033C , Exp. Date 6/27/2016 ; Service Code 2K8180 , Lot Number 160970035C , Exp. Date 6/30/2016 ; Service Code 2K8905 , Lot Number 160810187M , Exp. Date 6/11/2016 ; Service Code 2K8905 , Lot Number 160890186M , Exp. Date 6/18/2016 ; Service Code 2K8975 , Lot Number 160550132M , Exp. Date 5/15/2016 ; Service Code 2K8975 , Lot Number 160610229M , Exp. Date 5/22/2016 ; Service Code 2K8975 , Lot Number 160770165M , Exp. Date 6/7/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1415-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1415-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,470 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 160520118M , Exp. Date 5/22/2016 ; Service Code 2K8284 , Lot Number 160610207M , Exp. Date 5/31/2016 ; Service Code 2K8284 , Lot Number 160620153M , Exp. Date 6/1/2016 ; Service Code 2K8284 , Lot Number 160750236M , Exp. Date 6/14/2016 ; Service Code 2K8284 , Lot Number 160770226M , Exp. Date 6/16/2016 ; Service Code 2K8284 , Lot Number 160840209M , Exp. Date 6/23/2016 ; Service Code 2K8284 , Lot Number 160910218M , Exp. Date 6/30/2016 ; Service Code 2K8284 , Lot Number 160960157M , Exp. Date 7/5/2016 ; Service Code 2K8284 , Lot Number 161080227M , Exp. Date 7/17/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1396-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1396-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 97,716 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 ; Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 ; Service Code 3V8705 , Lot Number 160530278M , Exp. Date 5/23/2016 ; Service Code 3V8705 , Lot Number 160610204M , Exp. Date 5/31/2016 ; Service Code 3V8705 , Lot Number 160630155M , Exp. Date 6/2/2016 ; Service Code 3V8705 , Lot Number 160700159M , Exp. Date 6/9/2016 ; Service Code 3V8705 , Lot Number 160770234M , Exp. Date 6/16/2016 ; Service Code 3V8705 , Lot Number 160800199M , Exp. Date 6/19/2016 ; Service Code 3V8705 , Lot Number 160840217M , Exp. Date 6/23/2016 ; Service Code 3V8705 , Lot Number 161080171M , Exp. Date 7/17/2016 ; Service Code 3V8707 , Lot Number 160460233M , Exp. Date 5/10/2016 ; Service Code 3V8707 , Lot Number 160530170M , Exp. Date 5/17/2016 ; Service Code 3V8707 , Lot Number 160660139M , Exp. Date 5/30/2016 ; Service Code 3V8707 , Lot Number 160670160M , Exp. Date 5/31/2016 ; Service Code 3V8707 , Lot Number 160730245M , Exp. Date 6/6/2016 ; Service Code 3V8707 , Lot Number 160810188M , Exp. Date 6/14/2016 ; Service Code 3V8707 , Lot Number 160880197M , Exp. Date 6/21/2016 ; Service Code 3V8707 , Lot Number 160940223M , Exp. Date 6/27/2016 ; Service Code 3V8707 , Lot Number 160960010M , Exp. Date 6/28/2016 ; Service Code 2C8124 , Lot Number 160870072M , Exp. Date 5/11/2016 ; Service Code 2C8124 , Lot Number 160960047M , Exp. Date 5/20/2016 ; Service Code 2C8205 , Lot Number 160810170M , Exp. Date 5/6/2016 ; Service Code 2C8205 , Lot Number 160890184M , Exp. Date 5/14/2016 ; Service Code 2C8205 , Lot Number 160910167M , Exp. Date 5/15/2016 ; Service Code 2C8205 , Lot Number 160970129M , Exp. Date 5/21/2016 ; Service Code 2H8125 , Lot Number 160420030M , Exp. Date 5/8/2016 ; Service Code 2H8125 , Lot Number 160450359M , Exp. Date 5/11/2016 ; Service Code 2H8125 , Lot Number 160460339M , Exp. Date 5/12/2016 ; Service Code 2H8125 , Lot Number 160490036M , Exp. Date 5/15/2016 ; Service Code 2H8125 , Lot Number 160550173M , Exp. Date 5/21/2016 ; Service Code 2H8125 , Lot Number 160590318M , Exp. Date 5/25/2016 ; Service Code 2H8125 , Lot Number 160620310M , Exp. Date 5/28/2016 ; Service Code 2H8125 , Lot Number 160670054M , Exp. Date 6/2/2016 ; Service Code 2H8125 , Lot Number 160700048M , Exp. Date 6/5/2016 ; Service Code 2H8125 , Lot Number 160770057M , Exp. Date 6/12/2016 ; Service Code 2H8125 , Lot Number 160820240M , Exp. Date 6/17/2016 ; Service Code 2H8125 , Lot Number 160830048M , Exp. Date 6/18/2016 ; Service Code 2H8125 , Lot Number 160880059M , Exp. Date 6/23/2016 ; Service Code 2H8125 , Lot Number 160910192M , Exp. Date 6/26/2016 ; Service Code 2H8125 , Lot Number 160960058M , Exp. Date 7/1/2016 ; Service Code 2H8204 , Lot Number 160600191M , Exp. Date 5/16/2016 ; Service Code 2H8204 , Lot Number 160680245M , Exp. Date 5/24/2016 ; Service Code 2H8204 , Lot Number 160700134M , Exp. Date 5/25/2016 ; Service Code 2H8204 , Lot Number 160740161M , Exp. Date 5/30/2016 ; Service Code 2H8204 , Lot Number 160750188M , Exp. Date 5/31/2016 ; Service Code 2H8204 , Lot Number 160810201M , Exp. Date 6/6/2016 ; Service Code 2H8204 , Lot Number 160910156M , Exp. Date 6/16/2016 ; Service Code 2H8204 , Lot Number 161080147M , Exp. Date 7/3/2016 ; Service Code 2H8205 , Lot Number 160460042M , Exp. Date 5/16/2016 ; Service Code 2H8205 , Lot Number 160530269M , Exp. Date 5/23/2016 ; Service Code 2H8205 , Lot Number 160600058M , Exp. Date 5/30/2016 ; Service Code 2H8205 , Lot Number 160670225M , Exp. Date 6/6/2016 ; Service Code 2H8205 , Lot Number 160700039M , Exp. Date 6/9/2016 ; Service Code 2H8205 , Lot Number 160750027M , Exp. Date 6/14/2016 ; Service Code 2H8205 , Lot Number 160810038M , Exp. Date 6/20/2016 ; Service Code 2H8205 , Lot Number 160870101M , Exp. Date 6/26/2016 ; Service Code 2H8205 , Lot Number 160890057M , Exp. Date 6/28/2016 ; Service Code 2H8205 , Lot Number 160960177M , Exp. Date 7/5/2016 ; Service Code 2H8205 , Lot Number 161080083M , Exp. Date 7/17/2016 ; Service Code 2K8104 , Lot Number 160600066M , Exp. Date 5/24/2016 ; Service Code 2K8104 , Lot Number 160670228M , Exp. Date 5/31/2016 ; Service Code 2K8104 , Lot Number 160810299M , Exp. Date 6/14/2016 ; Service Code 2K8104 , Lot Number 160820210M , Exp. Date 6/15/2016 ; Service Code 2K8104 , Lot Number 160950235M , Exp. Date 6/28/2016 ; Service Code 2K8104 , Lot Number 160970132M , Exp. Date 6/30/2016 ; Service Code 2K8124 , Lot Number 160380046M , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160380047C , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160380049C , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160380180M , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160380181M , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160380305M , Exp. Date 5/8/2016 ; Service Code 2K8124 , Lot Number 160410050M , Exp. Date 5/11/2016 ; Service Code 2K8124 , Lot Number 160410054C , Exp. Date 5/11/2016 ; Service Code 2K8124 , Lot Number 160410056C , Exp. Date 5/11/2016 ; Service Code 2K8124 , Lot Number 160410308M , Exp. Date 5/11/2016 ; Service Code 2K8124 , Lot Number 160420050C , Exp. Date 5/12/2016 ; Service Code 2K8124 , Lot Number 160420051C , Exp. Date 5/12/2016 ; Service Code 2K8124 , Lot Number 160420054M , Exp. Date 5/12/2016 ; Service Code 2K8124 , Lot Number 160420336M , Exp. Date 5/12/2016 ; Service Code 2K8124 , Lot Number 160450064C , Exp. Date 5/15/2016 ; Service Code 2K8124 , Lot Number 160450066M , Exp. Date 5/15/2016 ; Service Code 2K8124 , Lot Number 160450067M , Exp. Date 5/15/2016 ; Service Code 2K8124 , Lot Number 160460059C , Exp. Date 5/16/2016 ; Service Code 2K8124 , Lot Number 160470067C , Exp. Date 5/17/2016 ; Service Code 2K8124 , Lot Number 160490022C , Exp. Date 5/19/2016 ; Service Code 2K8124 , Lot Number 160490046M , Exp. Date 5/19/2016 ; Service Code 2K8124 , Lot Number 160490322M , Exp. Date 5/19/2016 ; Service Code 2K8124 , Lot Number 160520008C , Exp. Date 5/22/2016 ; Service Code 2K8124 , Lot Number 160530030C , Exp. Date 5/23/2016 ; Service Code 2K8124 , Lot Number 160530031C , Exp. Date 5/23/2016 ; Service Code 2K8124 , Lot Number 160530060M , Exp. Date 5/23/2016 ; Service Code 2K8124 , Lot Number 160540054C , Exp. Date 5/24/2016 ; Service Code 2K8124 , Lot Number 160550056C , Exp. Date 5/25/2016 ; Service Code 2K8124 , Lot Number 160560033M , Exp. Date 5/26/2016 ; Service Code 2K8124 , Lot Number 160560034M , Exp. Date 5/26/2016 ; Service Code 2K8124 , Lot Number 160560050C , Exp. Date 5/26/2016 ; Service Code 2K8124 , Lot Number 160590051C , Exp. Date 5/29/2016 ; Service Code 2K8124 , Lot Number 160590110M , Exp. Date 5/29/2016 ; Service Code 2K8124 , Lot Number 160590323M , Exp. Date 5/29/2016 ; Service Code 2K8124 , Lot Number 160600025C , Exp. Date 5/30/2016 ; Service Code 2K8124 , Lot Number 160610030C , Exp. Date 5/31/2016 ; Service Code 2K8124 , Lot Number 160610078M , Exp. Date 5/30/2016 ; Service Code 2K8124 , Lot Number 160620012C , Exp. Date 6/1/2016 ; Service Code 2K8124 , Lot Number 160620052M , Exp. Date 6/1/2016 ; Service Code 2K8124 , Lot Number 160620053M , Exp. Date 6/1/2016 ; Service Code 2K8124 , Lot Number 160620056C , Exp. Date 6/1/2016 ; Service Code 2K8124 , Lot Number 160630049C , Exp. Date 6/2/2016 ; Service Code 2K8124 , Lot Number 160630051C , Exp. Date 6/2/2016 ; Service Code 2K8124 , Lot Number 160660009C , Exp. Date 6/5/2016 ; Service Code 2K8124 , Lot Number 160660054C , Exp. Date 6/5/2016 ; Service Code 2K8124 , Lot Number 160660055C , Exp. Date 6/5/2016 ; Service Code 2K8124 , Lot Number 160660092M , Exp. Date 6/5/2016 ; Service Code 2K8124 , Lot Number 160670091C , Exp. Date 6/6/2016 ; Service Code 2K8124 , Lot Number 160680339M , Exp. Date 6/7/2016 ; Service Code 2K8124 , Lot Number 160680340M , Exp. Date 6/7/2016 ; Service Code 2K8124 , Lot Number 160690054C , Exp. Date 6/8/2016 ; Service Code 2K8124 , Lot Number 160700052M , Exp. Date 6/9/2016 ; Service Code 2K8124 , Lot Number 160730059C , Exp. Date 6/12/2016 ; Service Code 2K8124 , Lot Number 160730348M , Exp. Date 6/12/2016 ; Service Code 2K8124 , Lot Number 160740010C , Exp. Date 6/13/2016 ; Service Code 2K8124 , Lot Number 160740011C , Exp. Date 6/13/2016 ; Service Code 2K8124 , Lot Number 160740318M , Exp. Date 6/13/2016 ; Service Code 2K8124 , Lot Number 160750038C , Exp. Date 6/14/2016 ; Service Code 2K8124 , Lot Number 160760019C , Exp. Date 6/15/2016 ; Service Code 2K8124 , Lot Number 160760053M , Exp. Date 6/15/2016 ; Service Code 2K8124 , Lot Number 160760069C , Exp. Date 6/15/2016 ; Service Code 2K8124 , Lot Number 160770060M , Exp. Date 6/16/2016 ; Service Code 2K8124 , Lot Number 160770068C , Exp. Date 6/16/2016 ; Service Code 2K8124 , Lot Number 160800067C , Exp. Date 6/20/2016 ; Service Code 2K8124 , Lot Number 160800307M , Exp. Date 6/19/2016 ; Service Code 2K8124 , Lot Number 160810021C , Exp. Date 6/20/2016 ; Service Code 2K8124 , Lot Number 160810067M , Exp. Date 6/20/2016 ; Service Code 2K8124 , Lot Number 160820014C , Exp. Date 6/21/2016 ; Service Code 2K8124 , Lot Number 160820072M , Exp. Date 6/21/2016 ; Service Code 2K8124 , Lot Number 160820310M , Exp. Date 6/21/2016 ; Service Code 2K8124 , Lot Number 160830019C , Exp. Date 6/22/2016 ; Service Code 2K8124 , Lot Number 160830058M , Exp. Date 6/22/2016 ; Service Code 2K8124 , Lot Number 160840005C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840068C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840069C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840070C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840075C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840076C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840077C , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160840185M , Exp. Date 6/23/2016 ; Service Code 2K8124 , Lot Number 160880062M , Exp. Date 6/27/2016 ; Service Code 2K8124 , Lot Number 160880087C , Exp. Date 6/27/2016 ; Service Code 2K8124 , Lot Number 160880089C , Exp. Date 6/27/2016 ; Service Code 2K8124 , Lot Number 160890063C , Exp. Date 6/28/2016 ; Service Code 2K8124 , Lot Number 160900136C , Exp. Date 6/29/2016 ; Service Code 2K8124 , Lot Number 160900144C , Exp. Date 6/29/2016 ; Service Code 2K8124 , Lot Number 160900315M , Exp. Date 6/29/2016 ; Service Code 2K8124 , Lot Number 160900316M , Exp. Date 6/29/2016 ; Service Code 2K8124 , Lot Number 160910306M , Exp. Date 6/30/2016 ; Service Code 2K8124 , Lot Number 160940322M , Exp. Date 7/3/2016 ; Service Code 2K8124 , Lot Number 160940323M , Exp. Date 7/3/2016 ; Service Code 2K8124 , Lot Number 160950077M , Exp. Date 7/4/2016 ; Service Code 2K8124 , Lot Number 160950095C , Exp. Date 7/4/2016 ; Service Code 2K8124 , Lot Number 160960070C , Exp. Date 7/5/2016 ; Service Code 2K8124 , Lot Number 160960071C , Exp. Date 7/5/2016 ; Service Code 2K8124 , Lot Number 160960072C , Exp. Date 7/5/2016 ; Service Code 2K8204 , Lot Number 160420344M , Exp. Date 5/6/2016 ; Service Code 2K8204 , Lot Number 160450077M , Exp. Date 5/9/2016 ; Service Code 2K8204 , Lot Number 160500003M , Exp. Date 5/13/2016 ; Service Code 2K8204 , Lot Number 160520296M , Exp. Date 5/16/2016 ; Service Code 2K8204 , Lot Number 160540224M , Exp. Date 5/18/2016 ; Service Code 2K8204 , Lot Number 160540341M , Exp. Date 5/18/2016 ; Service Code 2K8204 , Lot Number 160560038M , Exp. Date 5/20/2016 ; Service Code 2K8204 , Lot Number 160560318M , Exp. Date 5/20/2016 ; Service Code 2K8204 , Lot Number 160620325M , Exp. Date 5/26/2016 ; Service Code 2K8204 , Lot Number 160660106M , Exp. Date 5/30/2016 ; Service Code 2K8204 , Lot Number 160680063M , Exp. Date 6/1/2016 ; Service Code 2K8204 , Lot Number 160690286M , Exp. Date 6/2/2016 ; Service Code 2K8204 , Lot Number 160700312M , Exp. Date 6/3/2016 ; Service Code 2K8204 , Lot Number 160740226M , Exp. Date 6/7/2016 ; Service Code 2K8204 , Lot Number 160760169M , Exp. Date 6/9/2016 ; Service Code 2K8204 , Lot Number 160800123M , Exp. Date 6/13/2016 ; Service Code 2K8204 , Lot Number 160820043C , Exp. Date 6/15/2016 ; Service Code 2K8204 , Lot Number 160820327M , Exp. Date 6/15/2016 ; Service Code 2K8204 , Lot Number 160830320M , Exp. Date 6/16/2016 ; Service Code 2K8204 , Lot Number 160870339M , Exp. Date 6/20/2016 ; Service Code 2K8204 , Lot Number 160870340M , Exp. Date 6/20/2016 ; Service Code 2K8204 , Lot Number 160900059M , Exp. Date 6/23/2016 ; Service Code 2K8204 , Lot Number 160940331M , Exp. Date 6/27/2016 ; Service Code 2K8204 , Lot Number 160950332M , Exp. Date 6/28/2016 ; Service Code 2K8204 , Lot Number 160970299M , Exp. Date 6/30/2016 ; Service Code 2K8204 , Lot Number 160970300M , Exp. Date 6/30/2016 ; Service Code 2K8205 , Lot Number 160420345M , Exp. Date 5/6/2016 ; Service Code 2K8205 , Lot Number 160450069C , Exp. Date 5/9/2016 ; Service Code 2K8205 , Lot Number 160460043M , Exp. Date 5/10/2016 ; Service Code 2K8205 , Lot Number 160460065C , Exp. Date 5/10/2016 ; Service Code 2K8205 , Lot Number 160480042M , Exp. Date 5/12/2016 ; Service Code 2K8205 , Lot Number 160490023C , Exp. Date 5/13/2016 ; Service Code 2K8205 , Lot Number 160520059C , Exp. Date 5/16/2016 ; Service Code 2K8205 , Lot Number 160520297M , Exp. Date 5/16/2016 ; Service Code 2K8205 , Lot Number 160530062C , Exp. Date 5/17/2016 ; Service Code 2K8205 , Lot Number 160540056C , Exp. Date 5/18/2016 ; Service Code 2K8205 , Lot Number 160550050M , Exp. Date 5/19/2016 ; Service Code 2K8205 , Lot Number 160560013C , Exp. Date 5/20/2016 ; Service Code 2K8205 , Lot Number 160560039M , Exp. Date 5/20/2016 ; Service Code 2K8205 , Lot Number 160560319M , Exp. Date 5/20/2016 ; Service Code 2K8205 , Lot Number 160590058C , Exp. Date 5/23/2016 ; Service Code 2K8205 , Lot Number 160600027C , Exp. Date 5/24/2016 ; Service Code 2K8205 , Lot Number 160610346M , Exp. Date 5/25/2016 ; Service Code 2K8205 , Lot Number 160620009C , Exp. Date 5/26/2016 ; Service Code 2K8205 , Lot Number 160620326M , Exp. Date 5/26/2016 ; Service Code 2K8205 , Lot Number 160630010C , Exp. Date 5/27/2016 ; Service Code 2K8205 , Lot Number 160630051M , Exp. Date 5/27/2016 ; Service Code 2K8205 , Lot Number 160660052C , Exp. Date 5/30/2016 ; Service Code 2K8205 , Lot Number 160670092C , Exp. Date 5/31/2016 ; Service Code 2K8205 , Lot Number 160680015C , Exp. Date 6/1/2016 ; Service Code 2K8205 , Lot Number 160690010C , Exp. Date 6/2/2016 ; Service Code 2K8205 , Lot Number 160700027C , Exp. Date 6/3/2016 ; Service Code 2K8205 , Lot Number 160700313M , Exp. Date 6/3/2016 ; Service Code 2K8205 , Lot Number 160730015C , Exp. Date 6/6/2016 ; Service Code 2K8205 , Lot Number 160730119M , Exp. Date 6/6/2016 ; Service Code 2K8205 , Lot Number 160740028C , Exp. Date 6/7/2016 ; Service Code 2K8205 , Lot Number 160750204M , Exp. Date 6/8/2016 ; Service Code 2K8205 , Lot Number 160760037C , Exp. Date 6/9/2016 ; Service Code 2K8205 , Lot Number 160760292M , Exp. Date 6/9/2016 ; Service Code 2K8205 , Lot Number 160800011C , Exp. Date 6/13/2016 ; Service Code 2K8205 , Lot Number 160800124M , Exp. Date 6/13/2016 ; Service Code 2K8205 , Lot Number 160810022C , Exp. Date 6/14/2016 ; Service Code 2K8205 , Lot Number 160820024C , Exp. Date 6/15/2016 ; Service Code 2K8205 , Lot Number 160820025C , Exp. Date 6/15/2016 ; Service Code 2K8205 , Lot Number 160820042M , Exp. Date 6/15/2016 ; Service Code 2K8205 , Lot Number 160820081M , Exp. Date 6/15/2016 ; Service Code 2K8205 , Lot Number 160830018C , Exp. Date 6/16/2016 ; Service Code 2K8205 , Lot Number 160830321M , Exp. Date 6/16/2016 ; Service Code 2K8205 , Lot Number 160840066C , Exp. Date 6/17/2016 ; Service Code 2K8205 , Lot Number 160870068C , Exp. Date 6/20/2016 ; Service Code 2K8205 , Lot Number 160880067M , Exp. Date 6/21/2016 ; Service Code 2K8205 , Lot Number 160880101C , Exp. Date 6/21/2016 ; Service Code 2K8205 , Lot Number 160880102C , Exp. Date 6/21/2016 ; Service Code 2K8205 , Lot Number 160890071C , Exp. Date 6/22/2016 ; Service Code 2K8205 , Lot Number 160890074M , Exp. Date 6/22/2016 ; Service Code 2K8205 , Lot Number 160900149C , Exp. Date 6/23/2016 ; Service Code 2K8205 , Lot Number 160910057M , Exp. Date 6/24/2016 ; Service Code 2K8205 , Lot Number 160910059C , Exp. Date 6/24/2016 ; Service Code 2K8205 , Lot Number 160940332M , Exp. Date 6/27/2016 ; Service Code 2K8205 , Lot Number 160960078C , Exp. Date 6/29/2016 ; Service Code 2K8205 , Lot Number 160970063C , Exp. Date 6/30/2016 ; Service Code 2K8443 , Lot Number 160450221M , Exp. Date 5/15/2016 ; Service Code 2K8443 , Lot Number 160480164M , Exp. Date 5/18/2016 ; Service Code 2K8443 , Lot Number 160590107M , Exp. Date 5/29/2016 ; Service Code 2K8443 , Lot Number 160600334M , Exp. Date 5/30/2016 ; Service Code 2K8443 , Lot Number 160660272M , Exp. Date 6/5/2016 ; Service Code 2K8443 , Lot Number 160760204M , Exp. Date 6/15/2016 ; Service Code 2K8443 , Lot Number 160840177M , Exp. Date 6/23/2016 ; Service Code 2K8443 , Lot Number 160880288M , Exp. Date 6/27/2016 ; Service Code 2K8443 , Lot Number 160910239M , Exp. Date 6/30/2016 ; Service Code 2K8491 , Lot Number 160400214M , Exp. Date 5/10/2016 ; Service Code 2K8491 , Lot Number 160460269M , Exp. Date 5/16/2016 ; Service Code 2K8491 , Lot Number 160550158M , Exp. Date 5/25/2016 ; Service Code 2K8491 , Lot Number 160600333M , Exp. Date 5/30/2016 ; Service Code 2K8491 , Lot Number 160680258M , Exp. Date 6/7/2016 ; Service Code 2K8491 , Lot Number 160730283M , Exp. Date 6/12/2016 ; Service Code 2K8491 , Lot Number 160750252M , Exp. Date 6/14/2016 ; Service Code 2K8491 , Lot Number 160810275M , Exp. Date 6/20/2016 ; Service Code 2K8491 , Lot Number 160840236M , Exp. Date 6/23/2016 ; Service Code 2K8491 , Lot Number 160940267M , Exp. Date 7/3/2016 ; Service Code 2K8491 , Lot Number 161080278M , Exp. Date 7/17/2016 ; Service Code 2K8687 , Lot Number 160380048M , Exp. Date 5/8/2016 ; Service Code 2K8687 , Lot Number 160380187M , Exp. Date 5/8/2016 ; Service Code 2K8687 , Lot Number 160380188M , Exp. Date 5/8/2016 ; Service Code 2K8687 , Lot Number 160400176M , Exp. Date 5/10/2016 ; Service Code 2K8687 , Lot Number 160420039M , Exp. Date 5/12/2016 ; Service Code 2K8687 , Lot Number 160420055M , Exp. Date 5/12/2016 ; Service Code 2K8687 , Lot Number 160450080M , Exp. Date 5/15/2016 ; Service Code 2K8687 , Lot Number 160460351M , Exp. Date 5/16/2016 ; Service Code 2K8687 , Lot Number 160470329M , Exp. Date 5/17/2016 ; Service Code 2K8687 , Lot Number 160490052M , Exp. Date 5/18/2016 ; Service Code 2K8687 , Lot Number 160490335M , Exp. Date 5/19/2016 ; Service Code 2K8687 , Lot Number 160520081M , Exp. Date 5/21/2016 ; Service Code 2K8687 , Lot Number 160540344M , Exp. Date 5/24/2016 ; Service Code 2K8687 , Lot Number 160550335M , Exp. Date 5/25/2016 ; Service Code 2K8687 , Lot Number 160600383M , Exp. Date 5/30/2016 ; Service Code 2K8687 , Lot Number 160610348M , Exp. Date 5/31/2016 ; Service Code 2K8687 , Lot Number 160620061M , Exp. Date 6/1/2016 ; Service Code 2K8687 , Lot Number 160620330M , Exp. Date 6/1/2016 ; Service Code 2K8687 , Lot Number 160660111M , Exp. Date 6/5/2016 ; Service Code 2K8687 , Lot Number 160660112M , Exp. Date 6/5/2016 ; Service Code 2K8687 , Lot Number 160680148M , Exp. Date 6/7/2016 ; Service Code 2K8687 , Lot Number 160680346M , Exp. Date 6/7/2016 ; Service Code 2K8687 , Lot Number 160680347M , Exp. Date 6/7/2016 ; Service Code 2K8687 , Lot Number 160740325M , Exp. Date 6/13/2016 ; Service Code 2K8687 , Lot Number 160800114M , Exp. Date 6/19/2016 ; Service Code 2K8687 , Lot Number 160800126M , Exp. Date 6/19/2016 ; Service Code 2K8687 , Lot Number 160800127M , Exp. Date 6/19/2016 ; Service Code 2K8687 , Lot Number 160830322M , Exp. Date 6/22/2016 ; Service Code 2K8687 , Lot Number 160870125M , Exp. Date 6/26/2016 ; Service Code 2K8687 , Lot Number 160870126M , Exp. Date 6/26/2016 ; Service Code 2K8687 , Lot Number 160890373M , Exp. Date 6/28/2016 ; Service Code 2K8687 , Lot Number 160900063M , Exp. Date 6/29/2016 ; Service Code 2K8687 , Lot Number 160910059M , Exp. Date 6/29/2016 ; Service Code 2K8687 , Lot Number 160940009C , Exp. Date 7/3/2016 ; Service Code 2K8687 , Lot Number 160950338M , Exp. Date 7/4/2016 ; Service Code 2K8687 , Lot Number 160960330M , Exp. Date 7/5/2016 ; Service Code 2K8687 , Lot Number 160970303M , Exp. Date 7/6/2016 ; Service Code 2K8687 , Lot Number 161080102M , Exp. Date 7/17/2016 ; Service Code 2K8801 , Lot Number 160520031M , Exp. Date 5/12/2016 ; Service Code 2K8801 , Lot Number 160520032M , Exp. Date 5/13/2016 ; Service Code 2K8801 , Lot Number 160560173M , Exp. Date 5/17/2016 ; Service Code 2K8801 , Lot Number 160630163M , Exp. Date 5/24/2016 ; Service Code 2K8801 , Lot Number 160670261M , Exp. Date 5/28/2016 ; Service Code 2K8801 , Lot Number 160760198M , Exp. Date 6/6/2016 ; Service Code 2K8801 , Lot Number 160800110M , Exp. Date 6/10/2016 ; Service Code 2K8801 , Lot Number 160870185M , Exp. Date 6/17/2016 ; Service Code 2K8801 , Lot Number 160880286M , Exp. Date 6/18/2016 ; Service Code 2K8801 , Lot Number 160910226M , Exp. Date 6/21/2016 ; Service Code 2K8802 , Lot Number 160450071C , Exp. Date 5/6/2016 ; Service Code 2K8802 , Lot Number 160450074C , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160460068C , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160460071C , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160460264M , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160460265M , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160460325M , Exp. Date 5/7/2016 ; Service Code 2K8802 , Lot Number 160480068C , Exp. Date 5/9/2016 ; Service Code 2K8802 , Lot Number 160480070C , Exp. Date 5/9/2016 ; Service Code 2K8802 , Lot Number 160490070C , Exp. Date 5/10/2016 ; Service Code 2K8802 , Lot Number 160490072C , Exp. Date 5/10/2016 ; Service Code 2K8802 , Lot Number 160490315M , Exp. Date 5/10/2016 ; Service Code 2K8802 , Lot Number 160520279M , Exp. Date 5/13/2016 ; Service Code 2K8802 , Lot Number 160540031M , Exp. Date 5/15/2016 ; Service Code 2K8802 , Lot Number 160540321M , Exp. Date 5/15/2016 ; Service Code 2K8802 , Lot Number 160550053M , Exp. Date 5/16/2016 ; Service Code 2K8802 , Lot Number 160550061C , Exp. Date 5/16/2016 ; Service Code 2K8802 , Lot Number 160550062C , Exp. Date 5/15/2016 ; Service Code 2K8802 , Lot Number 160550299M , Exp. Date 5/16/2016 ; Service Code 2K8802 , Lot Number 160560040M , Exp. Date 5/17/2016 ; Service Code 2K8802 , Lot Number 160560056C , Exp. Date 5/17/2016 ; Service Code 2K8802 , Lot Number 160560059C , Exp. Date 5/17/2016 ; Service Code 2K8802 , Lot Number 160590059C , Exp. Date 5/20/2016 ; Service Code 2K8802 , Lot Number 160590205M , Exp. Date 5/20/2016 ; Service Code 2K8802 , Lot Number 160590206M , Exp. Date 5/19/2016 ; Service Code 2K8802 , Lot Number 160600075C , Exp. Date 5/21/2016 ; Service Code 2K8802 , Lot Number 160600098M , Exp. Date 5/21/2016 ; Service Code 2K8802 , Lot Number 160610064C , Exp. Date 5/22/2016 ; Service Code 2K8802 , Lot Number 160620037C , Exp. Date 5/23/2016 ; Service Code 2K8802 , Lot Number 160620059C , Exp. Date 5/23/2016 ; Service Code 2K8802 , Lot Number 160620060C , Exp. Date 5/23/2016 ; Service Code 2K8802 , Lot Number 160630022M , Exp. Date 5/24/2016 ; Service Code 2K8802 , Lot Number 160630060C , Exp. Date 5/24/2016 ; Service Code 2K8802 , Lot Number 160630141M , Exp. Date 5/24/2016 ; Service Code 2K8802 , Lot Number 160660053C , Exp. Date 5/27/2016 ; Service Code 2K8802 , Lot Number 160660332M , Exp. Date 5/27/2016 ; Service Code 2K8802 , Lot Number 160670060M , Exp. Date 5/28/2016 ; Service Code 2K8802 , Lot Number 160670312M , Exp. Date 5/28/2016 ; Service Code 2K8802 , Lot Number 160680063C , Exp. Date 5/29/2016 ; Service Code 2K8802 , Lot Number 160690059C , Exp. Date 5/30/2016 ; Service Code 2K8802 , Lot Number 160690060C , Exp. Date 5/29/2016 ; Service Code 2K8802 , Lot Number 160700291M , Exp. Date 5/31/2016 ; Service Code 2K8802 , Lot Number 160740032C , Exp. Date 6/4/2016 ; Service Code 2K8802 , Lot Number 160740033C , Exp. Date 6/4/2016 ; Service Code 2K8802 , Lot Number 160740313M , Exp. Date 6/4/2016 ; Service Code 2K8802 , Lot Number 160750269M , Exp. Date 6/5/2016 ; Service Code 2K8802 , Lot Number 160760028C , Exp. Date 6/6/2016 ; Service Code 2K8802 , Lot Number 160760029C , Exp. Date 6/6/2016 ; Service Code 2K8802 , Lot Number 160760071C , Exp. Date 6/6/2016 ; Service Code 2K8802 , Lot Number 160760267M , Exp. Date 6/6/2016 ; Service Code 2K8802 , Lot Number 160770063M , Exp. Date 6/7/2016 ; Service Code 2K8802 , Lot Number 160770070C , Exp. Date 6/7/2016 ; Service Code 2K8802 , Lot Number 160800071C , Exp. Date 6/10/2016 ; Service Code 2K8802 , Lot Number 160810071M , Exp. Date 6/11/2016 ; Service Code 2K8802 , Lot Number 160820295M , Exp. Date 6/12/2016 ; Service Code 2K8802 , Lot Number 160830044C , Exp. Date 6/13/2016 ; Service Code 2K8802 , Lot Number 160830045C , Exp. Date 6/13/2016 ; Service Code 2K8802 , Lot Number 160830063M , Exp. Date 6/13/2016 ; Service Code 2K8802 , Lot Number 160830064M , Exp. Date 6/13/2016 ; Service Code 2K8802 , Lot Number 160840020C , Exp. Date 6/13/2016 ; Service Code 2K8802 , Lot Number 160870070C , Exp. Date 6/17/2016 ; Service Code 2K8802 , Lot Number 160870071C , Exp. Date 6/16/2016 ; Service Code 2K8802 , Lot Number 160870207M , Exp. Date 6/17/2016 ; Service Code 2K8802 , Lot Number 160890022C , Exp. Date 6/19/2016 ; Service Code 2K8802 , Lot Number 160890078C , Exp. Date 6/19/2016 ; Service Code 2K8802 , Lot Number 160900104C , Exp. Date 6/20/2016 ; Service Code 2K8802 , Lot Number 160900138C , Exp. Date 6/20/2016 ; Service Code 2K8802 , Lot Number 160900190M , Exp. Date 6/20/2016 ; Service Code 2K8802 , Lot Number 160900298M , Exp. Date 6/20/2016 ; Service Code 2K8802 , Lot Number 160910060C , Exp. Date 6/21/2016 ; Service Code 2K8802 , Lot Number 160910060M , Exp. Date 6/21/2016 ; Service Code 2K8802 , Lot Number 160910298M , Exp. Date 6/21/2016 ; Service Code 2K8802 , Lot Number 160940074C , Exp. Date 6/24/2016 ; Service Code 2K8802 , Lot Number 160950102C , Exp. Date 6/25/2016 ; Service Code 2K8802 , Lot Number 160960067M , Exp. Date 6/26/2016 ; Service Code 2K8802 , Lot Number 160960083C , Exp. Date 6/26/2016 ; Service Code 2K8802 , Lot Number 160970008C , Exp. Date 6/27/2016 ; Service Code 2K8802 , Lot Number 160970055C , Exp. Date 6/27/2016 ; Service Code 2K8802 , Lot Number 161080184M , Exp. Date 7/8/2016 ; Service Code 2K8861 , Lot Number 160470040M , Exp. Date 5/8/2016 ; Service Code 2K8861 , Lot Number 160480342M , Exp. Date 5/9/2016 ; Service Code 2K8861 , Lot Number 160540027M , Exp. Date 5/15/2016 ; Service Code 2K8861 , Lot Number 160560001M , Exp. Date 5/16/2016 ; Service Code 2K8861 , Lot Number 160590306M , Exp. Date 5/20/2016 ; Service Code 2K8861 , Lot Number 160610054M , Exp. Date 5/22/2016 ; Service Code 2K8861 , Lot Number 160620301M , Exp. Date 5/23/2016 ; Service Code 2K8861 , Lot Number 160670042M , Exp. Date 5/28/2016 ; Service Code 2K8861 , Lot Number 160670314M , Exp. Date 5/28/2016 ; Service Code 2K8861 , Lot Number 160680333M , Exp. Date 5/29/2016 ; Service Code 2K8861 , Lot Number 160740314M , Exp. Date 6/4/2016 ; Service Code 2K8861 , Lot Number 160750321M , Exp. Date 6/5/2016 ; Service Code 2K8861 , Lot Number 160810073M , Exp. Date 6/11/2016 ; Service Code 2K8861 , Lot Number 160820069M , Exp. Date 6/12/2016 ; Service Code 2K8861 , Lot Number 160840295M , Exp. Date 6/14/2016 ; Service Code 2K8861 , Lot Number 160890080M , Exp. Date 6/19/2016 ; Service Code 2K8861 , Lot Number 160940092M , Exp. Date 6/24/2016 ; Service Code 2K8861 , Lot Number 160950084M , Exp. Date 6/25/2016 ; Service Code 2K8861 , Lot Number 160960307M , Exp. Date 6/26/2016 ; Service Code 2K8861 , Lot Number 161080192M , Exp. Date 7/8/2016 ; Service Code 2K8870 , Lot Number 160450070C , Exp. Date 5/6/2016 ; Service Code 2K8870 , Lot Number 160450073C , Exp. Date 5/6/2016 ; Service Code 2K8870 , Lot Number 160460067C , Exp. Date 5/7/2016 ; Service Code 2K8870 , Lot Number 160460070C , Exp. Date 5/8/2016 ; Service Code 2K8870 , Lot Number 160460332M , Exp. Date 5/7/2016 ; Service Code 2K8870 , Lot Number 160480067C , Exp. Date 5/9/2016 ; Service Code 2K8870 , Lot Number 160480069C , Exp. Date 5/9/2016 ; Service Code 2K8870 , Lot Number 160490069C , Exp. Date 5/9/2016 ; Service Code 2K8870 , Lot Number 160490071C , Exp. Date 5/10/2016 ; Service Code 2K8870 , Lot Number 160490220M , Exp. Date 5/10/2016 ; Service Code 2K8870 , Lot Number 160490321M , Exp. Date 5/10/2016 ; Service Code 2K8870 , Lot Number 160530028M , Exp. Date 5/14/2016 ; Service Code 2K8870 , Lot Number 160530029M , Exp. Date 5/14/2016 ; Service Code 2K8870 , Lot Number 160530063C , Exp. Date 5/14/2016 ; Service Code 2K8870 , Lot Number 160540053M , Exp. Date 5/15/2016 ; Service Code 2K8870 , Lot Number 160540057C , Exp. Date 5/15/2016 ; Service Code 2K8870 , Lot Number 160540058C , Exp. Date 5/15/2016 ; Service Code 2K8870 , Lot Number 160550063C , Exp. Date 5/16/2016 ; Service Code 2K8870 , Lot Number 160560055C , Exp. Date 5/17/2016 ; Service Code 2K8870 , Lot Number 160560058C , Exp. Date 5/17/2016 ; Service Code 2K8870 , Lot Number 160560297M , Exp. Date 5/17/2016 ; Service Code 2K8870 , Lot Number 160590308M , Exp. Date 5/20/2016 ; Service Code 2K8870 , Lot Number 160600074C , Exp. Date 5/21/2016 ; Service Code 2K8870 , Lot Number 160610063C , Exp. Date 5/22/2016 ; Service Code 2K8870 , Lot Number 160610082M , Exp. Date 5/22/2016 ; Service Code 2K8870 , Lot Number 160620052C , Exp. Date 5/23/2016 ; Service Code 2K8870 , Lot Number 160630058C , Exp. Date 5/24/2016 ; Service Code 2K8870 , Lot Number 160630058M , Exp. Date 5/24/2016 ; Service Code 2K8870 , Lot Number 160630059C , Exp. Date 5/24/2016 ; Service Code 2K8870 , Lot Number 160670316M , Exp. Date 5/28/2016 ; Service Code 2K8870 , Lot Number 160680061C , Exp. Date 5/29/2016 ; Service Code 2K8870 , Lot Number 160680062C , Exp. Date 5/30/2016 ; Service Code 2K8870 , Lot Number 160690061C , Exp. Date 5/30/2016 ; Service Code 2K8870 , Lot Number 160690062M , Exp. Date 5/30/2016 ; Service Code 2K8870 , Lot Number 160690114M , Exp. Date 5/30/2016 ; Service Code 2K8870 , Lot Number 160690266M , Exp. Date 5/30/2016 ; Service Code 2K8870 , Lot Number 160730065C , Exp. Date 6/3/2016 ; Service Code 2K8870 , Lot Number 160740030C , Exp. Date 6/4/2016 ; Service Code 2K8870 , Lot Number 160740031C , Exp. Date 6/4/2016 ; Service Code 2K8870 , Lot Number 160740315M , Exp. Date 6/4/2016 ; Service Code 2K8870 , Lot Number 160750031C , Exp. Date 6/5/2016 ; Service Code 2K8870 , Lot Number 160750069M , Exp. Date 6/5/2016 ; Service Code 2K8870 , Lot Number 160760066C , Exp. Date 6/5/2016 ; Service Code 2K8870 , Lot Number 160760067C , Exp. Date 6/6/2016 ; Service Code 2K8870 , Lot Number 160760272M , Exp. Date 6/6/2016 ; Service Code 2K8870 , Lot Number 160770069C , Exp. Date 6/7/2016 ; Service Code 2K8870 , Lot Number 160800292M , Exp. Date 6/10/2016 ; Service Code 2K8870 , Lot Number 160810030M , Exp. Date 6/11/2016 ; Service Code 2K8870 , Lot Number 160810074M , Exp. Date 6/11/2016 ; Service Code 2K8870 , Lot Number 160820028C , Exp. Date 6/12/2016 ; Service Code 2K8870 , Lot Number 160820029C , Exp. Date 6/12/2016 ; Service Code 2K8870 , Lot Number 160820300M , Exp. Date 6/12/2016 ; Service Code 2K8870 , Lot Number 160840028C , Exp. Date 6/14/2016 ; Service Code 2K8870 , Lot Number 160840071C , Exp. Date 6/14/2016 ; Service Code 2K8870 , Lot Number 160870072C , Exp. Date 6/18/2016 ; Service Code 2K8870 , Lot Number 160870306M , Exp. Date 6/17/2016 ; Service Code 2K8870 , Lot Number 160890072C , Exp. Date 6/19/2016 ; Service Code 2K8870 , Lot Number 160890211M , Exp. Date 6/19/2016 ; Service Code 2K8870 , Lot Number 160890337M , Exp. Date 6/19/2016 ; Service Code 2K8870 , Lot Number 160900088C , Exp. Date 6/20/2016 ; Service Code 2K8870 , Lot Number 160900139C , Exp. Date 6/20/2016 ; Service Code 2K8870 , Lot Number 160910051C , Exp. Date 6/21/2016 ; Service Code 2K8870 , Lot Number 160910053C , Exp. Date 6/21/2016 ; Service Code 2K8870 , Lot Number 160910067C , Exp. Date 6/21/2016 ; Service Code 2K8 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1429-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1429-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 445 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016 ; Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016 ; Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016 ; Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016 ; Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016 ; Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016 ; Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016 ; Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016 ; Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016 ; Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016 ; Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016 ; Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016 ; Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016 ; Service Code 2H8477 , Lot Number 160960037M , Exp. Date 7/4/2016 ; Service Code 2H8477 , Lot Number 160970136M , Exp. Date 7/6/2016 ; Service Code 2K8477 , Lot Number 160520174M , Exp. Date 5/22/2016 ; Service Code 2K8477 , Lot Number 160890053M , Exp. Date 6/27/2016 ; Service Code 2K8477 , Lot Number 160940139M , Exp. Date 7/3/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1403-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1403-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 105 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160890247M , Exp. Date 6/28/2016 ; Lot Number 160380151M , Exp. Date 5/8/2016 ; Lot Number 160490238M , Exp. Date 5/19/2016 ; Lot Number 160550208M , Exp. Date 5/25/2016 ; Lot Number 160610062M , Exp. Date 5/30/2016 ; Lot Number 160630184M , Exp. Date 6/2/2016 ; Lot Number 160700191M , Exp. Date 6/9/2016 ; Lot Number 160750045M , Exp. Date 6/13/2016 ; Lot Number 160770156M , Exp. Date 6/16/2016 ; Lot Number 160910163M , Exp. Date 6/30/2016 ; Lot Number 160810279M , Exp. Date 6/20/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1378-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1378-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 65 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8143 , Lot Number 160830115M , Exp. Date 6/22/2016 ; Service Code 2H8143 , Lot Number 160910155M , Exp. Date 6/30/2016 ; Service Code 2K8448 , Lot Number 160480205M , Exp. Date 5/12/2016 ; Service Code 2K8448 , Lot Number 160610064M , Exp. Date 5/24/2016 ; Service Code 2K8448 , Lot Number 160760042M , Exp. Date 6/9/2016 ; Service Code 2K8448 , Lot Number 160890047M , Exp. Date 6/22/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1420-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1420-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 936 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp. Date 5/10/2016 ; Service Code 2K8130 , Lot Number 160490184M , Exp. Date 5/13/2016 ; Service Code 2K8130 , Lot Number 160540122M , Exp. Date 5/17/2016 ; Service Code 2K8130 , Lot Number 160590163M , Exp. Date 5/23/2016 ; Service Code 2K8130 , Lot Number 160610226M , Exp. Date 5/25/2016 ; Service Code 2K8130 , Lot Number 160630185M , Exp. Date 5/27/2016 ; Service Code 2K8130 , Lot Number 160670242M , Exp. Date 5/31/2016 ; Service Code 2K8130 , Lot Number 160680239M , Exp. Date 6/1/2016 ; Service Code 2K8130 , Lot Number 160730147M , Exp. Date 6/6/2016 ; Service Code 2K8130 , Lot Number 160750140M , Exp. Date 6/8/2016 ; Service Code 2K8130 , Lot Number 160770169M , Exp. Date 6/10/2016 ; Service Code 2K8130 , Lot Number 160820223M , Exp. Date 6/15/2016 ; Service Code 2K8130 , Lot Number 160840161M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 160850004M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 160960163M , Exp. Date 6/29/2016 ; Service Code 2K8214 , Lot Number 160480213M , Exp. Date 5/18/2016 ; Service Code 2K8214 , Lot Number 160490043C , Exp. Date 5/19/2016 ; Service Code 2K8214 , Lot Number 160660037M , Exp. Date 6/4/2016 ; Service Code 2K8214 , Lot Number 160680039M , Exp. Date 6/6/2016 ; Service Code 2K8214 , Lot Number 160700003M , Exp. Date 6/8/2016 ; Service Code 2K8214 , Lot Number 160770051M , Exp. Date 6/15/2016 ; Service Code 2K8214 , Lot Number 160840167M , Exp. Date 6/23/2016 ; Service Code 2K8214 , Lot Number 160900176M , Exp. Date 6/29/2016 ; Service Code 2K9130 , Lot Number 160470154M , Exp. Date 5/17/2016 ; Service Code 2K9130 , Lot Number 160520171M , Exp. Date 5/22/2016 ; Service Code 2K9130 , Lot Number 160670175M , Exp. Date 6/6/2016 ; Service Code 2K9130 , Lot Number 160870068M , Exp. Date 6/25/2016 ; Service Code 2T8214 , Lot Number 160480151M , Exp. Date 5/9/2016 ; Service Code 2T8214 , Lot Number 160490007M , Exp. Date 5/9/2016 ; Service Code 2T8214 , Lot Number 160550162M , Exp. Date 5/16/2016 ; Service Code 2T8214 , Lot Number 160560003M , Exp. Date 5/16/2016 ; Service Code 2T8214 , Lot Number 160600198M , Exp. Date 5/21/2016 ; Service Code 2T8214 , Lot Number 160610004M , Exp. Date 5/21/2016 ; Service Code 2T8214 , Lot Number 160680166M , Exp. Date 5/29/2016 ; Service Code 2T8214 , Lot Number 160740177M , Exp. Date 6/4/2016 ; Service Code 2T8214 , Lot Number 160810191M , Exp. Date 6/11/2016 ; Service Code 2T8214 , Lot Number 160880179M , Exp. Date 6/17/2016 ; Service Code 2T8214 , Lot Number 160910133M , Exp. Date 6/21/2016 ; Service Code 2T8214 , Lot Number 160960150M , Exp. Date 6/26/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1375-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1375-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,527 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 ; Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 ; Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 ; Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 ; Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 ; Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 ; Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 ; Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 ; Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 ; Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 ; Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 ; Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 ; Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 ; Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 ; Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 ; Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 ; Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 ; Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160880043C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160910014C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160910015C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160950071C , Exp. Date 6/25/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1426-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1426-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,927 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8139 , Lot Number 160420171M , Exp. Date 5/12/2016 ; Service Code 2H8139 , Lot Number 160460111M , Exp. Date 5/16/2016 ; Service Code 2H8139 , Lot Number 160490001M , Exp. Date 5/18/2016 ; Service Code 2H8139 , Lot Number 160530289M , Exp. Date 5/23/2016 ; Service Code 2H8139 , Lot Number 160560215M , Exp. Date 5/26/2016 ; Service Code 2H8139 , Lot Number 160590055M , Exp. Date 5/29/2016 ; Service Code 2H8139 , Lot Number 160600232M , Exp. Date 5/30/2016 ; Service Code 2H8139 , Lot Number 160610189M , Exp. Date 5/31/2016 ; Service Code 2H8139 , Lot Number 160670159M , Exp. Date 6/6/2016 ; Service Code 2H8139 , Lot Number 160740151M , Exp. Date 6/13/2016 ; Service Code 2H8139 , Lot Number 160770172M , Exp. Date 6/16/2016 ; Service Code 2H8139 , Lot Number 160800069M , Exp. Date 6/18/2016 ; Service Code 2H8139 , Lot Number 160810208M , Exp. Date 6/20/2016 ; Service Code 2H8139 , Lot Number 160900168M , Exp. Date 6/29/2016 ; Service Code 2H8139 , Lot Number 160960158M , Exp. Date 7/5/2016 ; Service Code 2H8139 , Lot Number 161080229M , Exp. Date 7/17/2016 ; Service Code 2H8140 , Lot Number 160450212M , Exp. Date 5/11/2016 ; Service Code 2H8140 , Lot Number 160550237M , Exp. Date 5/21/2016 ; Service Code 2H8140 , Lot Number 160660222M , Exp. Date 6/1/2016 ; Service Code 2H8140 , Lot Number 160670248M , Exp. Date 6/2/2016 ; Service Code 2H8140 , Lot Number 160700215M , Exp. Date 6/5/2016 ; Service Code 2H8140 , Lot Number 160870227M , Exp. Date 6/22/2016 ; Service Code 2H8140 , Lot Number 160880150M , Exp. Date 6/23/2016 ; Service Code 2H8140 , Lot Number 160940208M , Exp. Date 6/29/2016 ; Service Code 2H8140 , Lot Number 161080214M , Exp. Date 7/13/2016 ; Service Code 2K8139 , Lot Number 160450047M , Exp. Date 5/9/2016 ; Service Code 2K8139 , Lot Number 160590188M , Exp. Date 5/23/2016 ; Service Code 2K8139 , Lot Number 160610248M , Exp. Date 5/25/2016 ; Service Code 2K8139 , Lot Number 160730263M , Exp. Date 6/6/2016 ; Service Code 2K8139 , Lot Number 160770133M , Exp. Date 6/10/2016 ; Service Code 2K8139 , Lot Number 160820143M , Exp. Date 6/15/2016 ; Service Code 2K8139 , Lot Number 160880151M , Exp. Date 6/21/2016 ; Service Code 2K8139 , Lot Number 160910235M , Exp. Date 6/24/2016 ; Service Code 2K8247 , Lot Number 160400202M , Exp. Date 5/10/2016 ; Service Code 2K8247 , Lot Number 160460151M , Exp. Date 5/16/2016 ; Service Code 2K8247 , Lot Number 160470188M , Exp. Date 5/17/2016 ; Service Code 2K8247 , Lot Number 160590141M , Exp. Date 5/29/2016 ; Service Code 2K8247 , Lot Number 160620192M , Exp. Date 6/1/2016 ; Service Code 2K8247 , Lot Number 160700158M , Exp. Date 6/9/2016 ; Service Code 2K8247 , Lot Number 160820178M , Exp. Date 6/21/2016 ; Service Code 2K8247 , Lot Number 160840216M , Exp. Date 6/23/2016 ; Service Code 2K8247 , Lot Number 160910142M , Exp. Date 6/30/2016 ; Service Code 2K8247 , Lot Number 160940212M , Exp. Date 7/3/2016 ; Service Code 2K8247 , Lot Number 161080223M , Exp. Date 7/17/2016 ; Service Code 2K8813 , Lot Number 160450175M , Exp. Date 5/6/2016 ; Service Code 2K8813 , Lot Number 160460213M , Exp. Date 5/7/2016 ; Service Code 2K8813 , Lot Number 160480240M , Exp. Date 5/9/2016 ; Service Code 2K8813 , Lot Number 160520185M , Exp. Date 5/13/2016 ; Service Code 2K8813 , Lot Number 160560083M , Exp. Date 5/16/2016 ; Service Code 2K8813 , Lot Number 160630156M , Exp. Date 5/24/2016 ; Service Code 2K8813 , Lot Number 160700166M , Exp. Date 5/31/2016 ; Service Code 2K8813 , Lot Number 160770183M , Exp. Date 6/7/2016 ; Service Code 2K8813 , Lot Number 160830180M , Exp. Date 6/13/2016 ; Service Code 2K8813 , Lot Number 160910180M , Exp. Date 6/21/2016 ; Service Code 2K8875 , Lot Number 160660143M , Exp. Date 5/27/2016 ; Service Code 2K8875 , Lot Number 160770127M , Exp. Date 6/7/2016 ; Service Code 2K8875 , Lot Number 160940123M , Exp. Date 6/24/2016 ; Service Code 2K8876 , Lot Number 160490225M , Exp. Date 5/10/2016 ; Service Code 2K8876 , Lot Number 160540244M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160540245M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160630129M , Exp. Date 5/24/2016 ; Service Code 2K8876 , Lot Number 160700161M , Exp. Date 5/31/2016 ; Service Code 2K8876 , Lot Number 160770137M , Exp. Date 6/7/2016 ; Service Code 2K8876 , Lot Number 160810190M , Exp. Date 6/11/2016 ; Service Code 2K8876 , Lot Number 160830187M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830188M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830189M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160910229M , Exp. Date 6/21/2016 ; Service Code 2K8876 , Lot Number 161080079M , Exp. Date 7/7/2016 ; Service Code 2T6140 , Lot Number 160380106M , Exp. Date 5/7/2016 ; Service Code 2T6140 , Lot Number 160460193M , Exp. Date 5/16/2016 ; Service Code 2T6140 , Lot Number 160520182M , Exp. Date 5/22/2016 ; Service Code 2T6140 , Lot Number 160540193M , Exp. Date 5/23/2016 ; Service Code 2T6140 , Lot Number 160560094M , Exp. Date 5/25/2016 ; Service Code 2T6140 , Lot Number 160600050M , Exp. Date 5/29/2016 ; Service Code 2T6140 , Lot Number 160660153M , Exp. Date 6/5/2016 ; Service Code 2T6140 , Lot Number 160950214M , Exp. Date 7/4/2016 ; Service Code 2T6222 , Lot Number 160420160M , Exp. Date 5/11/2016 ; Service Code 2T8875 , Lot Number 160960145M , Exp. Date 5/6/2016 ; Service Code 2T8876 , Lot Number 160960131M , Exp. Date 5/6/2016 ; Service Code 4J8139 , Lot Number 160460122M , Exp. Date 5/10/2016 ; Service Code 4J8139 , Lot Number 160680045M , Exp. Date 5/31/2016 ; Service Code 4J8139 , Lot Number 160810171M , Exp. Date 6/14/2016 ; Service Code 4J8139 , Lot Number 160950057M , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1395-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1395-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 43,589 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 ; Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 ; Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 ; Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 ; Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 ; Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 ; Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 ; Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 ; Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 ; Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 ; Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 ; Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 ; Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160660249M , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160750261M , Exp. Date 6/8/2016 ; Service Code 3V8703 , Lot Number 160800218M , Exp. Date 6/13/2016 ; Service Code 3V8703 , Lot Number 160910144M , Exp. Date 6/24/2016 ; Service Code 3V8703 , Lot Number 160940249M , Exp. Date 6/27/2016 ; Service Code 3V8703 , Lot Number 161080258M , Exp. Date 7/11/2016 ; Service Code 2C8201 , Lot Number 160960246M , Exp. Date 5/21/2016 ; Service Code 2H8122 , Lot Number 160400260M , Exp. Date 5/6/2016 ; Service Code 2H8122 , Lot Number 160460244M , Exp. Date 5/12/2016 ; Service Code 2H8122 , Lot Number 160530172M , Exp. Date 5/19/2016 ; Service Code 2H8122 , Lot Number 160600231M , Exp. Date 5/26/2016 ; Service Code 2H8122 , Lot Number 160610162M , Exp. Date 5/27/2016 ; Service Code 2H8122 , Lot Number 160660246M , Exp. Date 6/1/2016 ; Service Code 2H8122 , Lot Number 160680217M , Exp. Date 6/3/2016 ; Service Code 2H8122 , Lot Number 160770255M , Exp. Date 6/12/2016 ; Service Code 2H8122 , Lot Number 160800216M , Exp. Date 6/15/2016 ; Service Code 2H8122 , Lot Number 160890198M , Exp. Date 6/24/2016 ; Service Code 2H8122 , Lot Number 160910120M , Exp. Date 6/26/2016 ; Service Code 2H8122 , Lot Number 160940211M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160390320M , Exp. Date 5/9/2016 ; Service Code 2H8131 , Lot Number 160460041M , Exp. Date 5/16/2016 ; Service Code 2H8131 , Lot Number 160480170M , Exp. Date 5/18/2016 ; Service Code 2H8131 , Lot Number 160530268M , Exp. Date 5/23/2016 ; Service Code 2H8131 , Lot Number 160600043M , Exp. Date 5/30/2016 ; Service Code 2H8131 , Lot Number 160660087M , Exp. Date 6/5/2016 ; Service Code 2H8131 , Lot Number 160700178M , Exp. Date 6/9/2016 ; Service Code 2H8131 , Lot Number 160750035M , Exp. Date 6/14/2016 ; Service Code 2H8131 , Lot Number 160810269M , Exp. Date 6/20/2016 ; Service Code 2H8131 , Lot Number 160870108M , Exp. Date 6/26/2016 ; Service Code 2H8131 , Lot Number 160900326M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160960059M , Exp. Date 7/5/2016 ; Service Code 2H8201 , Lot Number 160600054M , Exp. Date 5/16/2016 ; Service Code 2H8201 , Lot Number 160670235M , Exp. Date 5/23/2016 ; Service Code 2H8201 , Lot Number 160740184M , Exp. Date 5/30/2016 ; Service Code 2H8201 , Lot Number 160890267M , Exp. Date 6/14/2016 ; Service Code 2H8201 , Lot Number 160950054M , Exp. Date 6/19/2016 ; Service Code 2H8201 , Lot Number 160960004M , Exp. Date 6/20/2016 ; Service Code 2K8122 , Lot Number 160410134M , Exp. Date 5/7/2016 ; Service Code 2K8122 , Lot Number 160460125M , Exp. Date 5/12/2016 ; Service Code 2K8122 , Lot Number 160520111M , Exp. Date 5/17/2016 ; Service Code 2K8122 , Lot Number 160620030M , Exp. Date 5/27/2016 ; Service Code 2K8122 , Lot Number 160670147M , Exp. Date 6/2/2016 ; Service Code 2K8122 , Lot Number 160740165M , Exp. Date 6/9/2016 ; Service Code 2K8122 , Lot Number 160820129M , Exp. Date 6/17/2016 ; Service Code 2K8122 , Lot Number 160900134M , Exp. Date 6/25/2016 ; Service Code 2K8122 , Lot Number 160960144M , Exp. Date 7/1/2016 ; Service Code 2K8123 , Lot Number 160420053C , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160420252M , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160450066C , Exp. Date 5/15/2016 ; Service Code 2K8123 , Lot Number 160460028M , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160460061C , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160530266M , Exp. Date 5/23/2016 ; Service Code 2K8123 , Lot Number 160550023C , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160550048M , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160600017C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600018C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600092M , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160630013C , Exp. Date 6/2/2016 ; Service Code 2K8123 , Lot Number 160660086M , Exp. Date 6/5/2016 ; Service Code 2K8123 , Lot Number 160670048C , Exp. Date 6/6/2016 ; Service Code 2K8123 , Lot Number 160680061M , Exp. Date 6/7/2016 ; Service Code 2K8123 , Lot Number 160730009C , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160730347M , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160740056C , Exp. Date 6/13/2016 ; Service Code 2K8123 , Lot Number 160770021C , Exp. Date 6/16/2016 ; Service Code 2K8123 , Lot Number 160810032M , Exp. Date 6/20/2016 ; Service Code 2K8123 , Lot Number 160820031C , Exp. Date 6/21/2016 ; Service Code 2K8123 , Lot Number 160840046C , Exp. Date 6/23/2016 ; Service Code 2K8123 , Lot Number 160870061C , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160870106M , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160880344M , Exp. Date 6/27/2016 ; Service Code 2K8123 , Lot Number 160890065C , Exp. Date 6/28/2016 ; Service Code 2K8123 , Lot Number 160900152C , Exp. Date 6/29/2016 ; Service Code 2K8123 , Lot Number 160910037M , Exp. Date 6/30/2016 ; Service Code 2K8123 , Lot Number 160970069C , Exp. Date 7/6/2016 ; Service Code 2K8123 , Lot Number 161080082M , Exp. Date 7/17/2016 ; Service Code 2K8131 , Lot Number 160420213M , Exp. Date 5/6/2016 ; Service Code 2K8131 , Lot Number 160450363M , Exp. Date 5/9/2016 ; Service Code 2K8131 , Lot Number 160460066C , Exp. Date 5/10/2016 ; Service Code 2K8131 , Lot Number 160480027C , Exp. Date 5/12/2016 ; Service Code 2K8131 , Lot Number 160490047M , Exp. Date 5/13/2016 ; Service Code 2K8131 , Lot Number 160520063C , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160520294M , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160540021C , Exp. Date 5/18/2016 ; Service Code 2K8131 , Lot Number 160550019C , Exp. Date 5/19/2016 ; Service Code 2K8131 , Lot Number 160560035M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160560316M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160590127M , Exp. Date 5/23/2016 ; Service Code 2K8131 , Lot Number 160600045C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160600046C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160610014C , Exp. Date 5/25/2016 ; Service Code 2K8131 , Lot Number 160620014C , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620054M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620322M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160660017C , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160660351M , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160680014C , Exp. Date 6/1/2016 ; Service Code 2K8131 , Lot Number 160690285M , Exp. Date 6/2/2016 ; Service Code 2K8131 , Lot Number 160740034M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740052C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740053C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740054M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160750021C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160750022C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160760160M , Exp. Date 6/9/2016 ; Service Code 2K8131 , Lot Number 160770323M , Exp. Date 6/10/2016 ; Service Code 2K8131 , Lot Number 160800013C , Exp. Date 6/13/2016 ; Service Code 2K8131 , Lot Number 160810023C , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160810237M , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160820054C , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820197M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820326M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160840065C , Exp. Date 6/17/2016 ; Service Code 2K8131 , Lot Number 160870069C , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160870116M , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160880063M , Exp. Date 6/21/2016 ; Service Code 2K8131 , Lot Number 160890015C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160890016C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160900153C , Exp. Date 6/23/2016 ; Service Code 2K8131 , Lot Number 160910051M , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910056C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910058C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160940330M , Exp. Date 6/27/2016 ; Service Code 2K8131 , Lot Number 160950078M , Exp. Date 6/28/2016 ; Service Code 2K8131 , Lot Number 160960081C , Exp. Date 6/29/2016 ; Service Code 2K8201 , Lot Number 160420343M , Exp. Date 5/6/2016 ; Service Code 2K8201 , Lot Number 160460032M , Exp. Date 5/10/2016 ; Service Code 2K8201 , Lot Number 160520042M , Exp. Date 5/16/2016 ; Service Code 2K8201 , Lot Number 160540340M , Exp. Date 5/18/2016 ; Service Code 2K8201 , Lot Number 160600069M , Exp. Date 5/24/2016 ; Service Code 2K8201 , Lot Number 160630027M , Exp. Date 5/27/2016 ; Service Code 2K8201 , Lot Number 160670025M , Exp. Date 5/31/2016 ; Service Code 2K8201 , Lot Number 160680233M , Exp. Date 6/1/2016 ; Service Code 2K8201 , Lot Number 160740055M , Exp. Date 6/7/2016 ; Service Code 2K8201 , Lot Number 160810363M , Exp. Date 6/14/2016 ; Service Code 2K8201 , Lot Number 160870338M , Exp. Date 6/20/2016 ; Service Code 2K8201 , Lot Number 160890369M , Exp. Date 6/22/2016 ; Service Code 2K8201 , Lot Number 160950065M , Exp. Date 6/28/2016 ; Service Code 2K8442 , Lot Number 160460152M , Exp. Date 5/16/2016 ; Service Code 2K8442 , Lot Number 160600211M , Exp. Date 5/30/2016 ; Service Code 2K8442 , Lot Number 160610241M , Exp. Date 5/31/2016 ; Service Code 2K8442 , Lot Number 160740025M , Exp. Date 6/12/2016 ; Service Code 2K8442 , Lot Number 160750036M , Exp. Date 6/13/2016 ; Service Code 2K8442 , Lot Number 160960031M , Exp. Date 7/4/2016 ; Service Code 2K8442 , Lot Number 160970164M , Exp. Date 7/6/2016 ; Service Code 2K8490 , Lot Number 160390239M , Exp. Date 5/9/2016 ; Service Code 2K8490 , Lot Number 160490196M , Exp. Date 5/19/2016 ; Service Code 2K8490 , Lot Number 160660230M , Exp. Date 6/5/2016 ; Service Code 2K8490 , Lot Number 160770205M , Exp. Date 6/16/2016 ; Service Code 2K8490 , Lot Number 160800075M , Exp. Date 6/18/2016 ; Service Code 2K8490 , Lot Number 160810294M , Exp. Date 6/20/2016 ; Service Code 2K8490 , Lot Number 160870081M , Exp. Date 6/25/2016 ; Service Code 2K8490 , Lot Number 160950212M , Exp. Date 7/4/2016 ; Service Code 2K8689 , Lot Number 160410030M , Exp. Date 5/11/2016 ; Service Code 2K8689 , Lot Number 160490223M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160490224M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160540249M , Exp. Date 5/24/2016 ; Service Code 2K8689 , Lot Number 160620023M , Exp. Date 6/1/2016 ; Service Code 2K8689 , Lot Number 160660089M , Exp. Date 6/5/2016 ; Service Code 2K8689 , Lot Number 160680047M , Exp. Date 6/7/2016 ; Service Code 2K8689 , Lot Number 160730106M , Exp. Date 6/12/2016 ; Service Code 2K8689 , Lot Number 160760117M , Exp. Date 6/15/2016 ; Service Code 2K8689 , Lot Number 160820242M , Exp. Date 6/21/2016 ; Service Code 2K8689 , Lot Number 160870104M , Exp. Date 6/26/2016 ; Service Code 2K8689 , Lot Number 160890215M , Exp. Date 6/28/2016 ; Service Code 2K8689 , Lot Number 160950253M , Exp. Date 7/4/2016 ; Service Code 2K8803 , Lot Number 160530173M , Exp. Date 5/14/2016 ; Service Code 2K8803 , Lot Number 160740149M , Exp. Date 6/3/2016 ; Service Code 2K8803 , Lot Number 160800061M , Exp. Date 6/9/2016 ; Service Code 2K8803 , Lot Number 160880170M , Exp. Date 6/18/2016 ; Service Code 2K8803 , Lot Number 160950144M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160450088M , Exp. Date 5/6/2016 ; Service Code 2K8804 , Lot Number 160460252M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460253M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460326M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460327M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160490316M , Exp. Date 5/10/2016 ; Service Code 2K8804 , Lot Number 160530032M , Exp. Date 5/14/2016 ; Service Code 2K8804 , Lot Number 160540051M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160540322M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160560041M , Exp. Date 5/17/2016 ; Service Code 2K8804 , Lot Number 160590207M , Exp. Date 5/20/2016 ; Service Code 2K8804 , Lot Number 160610081M , Exp. Date 5/22/2016 ; Service Code 2K8804 , Lot Number 160620295M , Exp. Date 5/23/2016 ; Service Code 2K8804 , Lot Number 160630295M , Exp. Date 5/24/2016 ; Service Code 2K8804 , Lot Number 160660081M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160660333M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160680329M , Exp. Date 5/29/2016 ; Service Code 2K8804 , Lot Number 160700057M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160700292M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160730339M , Exp. Date 6/3/2016 ; Service Code 2K8804 , Lot Number 160750066M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160750317M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160760268M , Exp. Date 6/6/2016 ; Service Code 2K8804 , Lot Number 160800101M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160800160M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160810346M , Exp. Date 6/11/2016 ; Service Code 2K8804 , Lot Number 160820068M , Exp. Date 6/12/2016 ; Service Code 2K8804 , Lot Number 160840051M , Exp. Date 6/14/2016 ; Service Code 2K8804 , Lot Number 160870208M , Exp. Date 6/17/2016 ; Service Code 2K8804 , Lot Number 160890078M , Exp. Date 6/19/2016 ; Service Code 2K8804 , Lot Number 160910299M , Exp. Date 6/21/2016 ; Service Code 2K8804 , Lot Number 160940088M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160950306M , Exp. Date 6/25/2016 ; Service Code 2K8804 , Lot Number 160960068M , Exp. Date 6/26/2016 ; Service Code 2K8804 , Lot Number 161080069M , Exp. Date 7/8/2016 ; Service Code 2K8804 , Lot Number 161080185M , Exp. Date 7/8/2016 ; Service Code 2K8863 , Lot Number 160480267M , Exp. Date 5/9/2016 ; Service Code 2K8863 , Lot Number 160600342M , Exp. Date 5/21/2016 ; Service Code 2K8863 , Lot Number 160620124M , Exp. Date 5/23/2016 ; Service Code 2K8863 , Lot Number 160740265M , Exp. Date 6/4/2016 ; Service Code 2K8863 , Lot Number 160800219M , Exp. Date 6/10/2016 ; Service Code 2K8863 , Lot Number 160870249M , Exp. Date 6/17/2016 ; Service Code 2K8863 , Lot Number 160900028M , Exp. Date 6/20/2016 ; Service Code 2K8863 , Lot Number 160940251M , Exp. Date 6/24/2016 ; Service Code 2K8869 , Lot Number 160450345M , Exp. Date 5/6/2016 ; Service Code 2K8869 , Lot Number 160490074M , Exp. Date 5/9/2016 ; Service Code 2K8869 , Lot Number 160520286M , Exp. Date 5/13/2016 ; Service Code 2K8869 , Lot Number 160550062M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160550302M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160560045M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160560296M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160610328M , Exp. Date 5/22/2016 ; Service Code 2K8869 , Lot Number 160620303M , Exp. Date 5/23/2016 ; Service Code 2K8869 , Lot Number 160660339M , Exp. Date 5/27/2016 ; Service Code 2K8869 , Lot Number 160670066C , Exp. Date 5/28/2016 ; Service Code 2K8869 , Lot Number 160680192M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160680334M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160700296M , Exp. Date 5/31/2016 ; Service Code 2K8869 , Lot Number 160730341M , Exp. Date 6/3/2016 ; Service Code 2K8869 , Lot Number 160750162M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160750323M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160800291M , Exp. Date 6/10/2016 ; Service Code 2K8869 , Lot Number 160820169M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160820170M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160830303M , Exp. Date 6/13/2016 ; Service Code 2K8869 , Lot Number 160840182M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160840296M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160880338M , Exp. Date 6/18/2016 ; Service Code 2K8869 , Lot Number 160900301M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160900302M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160950025C , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160950311M , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160960308M , Exp. Date 6/26/2016 ; Service Code 2K8869 , Lot Number 160970273M , Exp. Date 6/27/2016 ; Service Code 2K8869 , Lot Number 161080193M , Exp. Date 7/8/2016 ; Service Code 2K9201 , Lot Number 160490243M , Exp. Date 5/19/2016 ; Service Code 2T6122 , Lot Number 160830171M , Exp. Date 6/22/2016 ; Service Code 2T6122 , Lot Number 160950184M , Exp. Date 7/4/2016 ; Service Code 2T8201 , Lot Number 160960288M , Exp. Date 5/6/2016 ; Service Code 2T8201 , Lot Number 161080318M , Exp. Date 5/18/2016 ; Service Code 2T8869 , Lot Number 160960048C , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160960289M , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160970071M , Exp. Date 5/7/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1419-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1419-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,828 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1402-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1402-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 95 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 ; Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 ; Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 ; Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 ; Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 ; Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 ; Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 ; Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1399-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1399-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-229-97
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 21 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot #160960135M; Exp. Date 5/6/2016 Lot #161080053M; Exp. Date 5/17/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1422-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1422-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 655 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 160880192M , Exp. Date 6/27/2016 ; Service Code 2K8254 , Lot Number 160890178M , Exp. Date 6/28/2016 ; Service Code 2K8256 , Lot Number 160480195M , Exp. Date 5/12/2016 ; Service Code 2K8256 , Lot Number 160530189M , Exp. Date 5/17/2016 ; Service Code 2K8256 , Lot Number 160560081M , Exp. Date 5/19/2016 ; Service Code 2K8256 , Lot Number 160590069M , Exp. Date 5/23/2016 ; Service Code 2K8256 , Lot Number 160660151M , Exp. Date 5/30/2016 ; Service Code 2K8256 , Lot Number 160680250M , Exp. Date 6/1/2016 ; Service Code 2K8256 , Lot Number 160880025M , Exp. Date 6/20/2016 ; Service Code 2K8256 , Lot Number 160950047M , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1383-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1383-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 55 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160470116M , Exp. Date 5/17/2016 ; Lot Number 160490123M , Exp. Date 5/19/2016 ; Lot Number 160800048M , Exp. Date 6/18/2016 ; Lot Number 160890060M , Exp. Date 6/27/2016 ; Lot Number 160940050M , Exp. Date 7/2/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1400-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1400-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 480 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160480033C , Exp. Date 5/12/2016 ; Lot Number 160520027C , Exp. Date 5/16/2016 ; Lot Number 160610040C , Exp. Date 5/25/2016 ; Lot Number 160750051C , Exp. Date 6/8/2016 ; Lot Number 160800038C , Exp. Date 6/13/2016 ; Lot Number 160880045C , Exp. Date 6/21/2016 ; Lot Number 160940037C , Exp. Date 6/27/2016 ; Lot Number 160960035C , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1401-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1401-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 90 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160420104M , Exp. Date 5/6/2016 ; Lot Number 160450187M , Exp. Date 5/9/2016 ; Lot Number 160530126M , Exp. Date 5/17/2016 ; Lot Number 160680200M , Exp. Date 6/1/2016 ; Lot Number 160730047M , Exp. Date 6/5/2016 ; Lot Number 160750130M , Exp. Date 6/8/2016 ; Lot Number 160830227M , Exp. Date 6/16/2016 ; Lot Number 160870077M , Exp. Date 6/19/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1425-206
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1425-206 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,713 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 ; Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 ; Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 ; Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 ; Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 ; Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 ; Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 ; Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 ; Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 ; Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 ; Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 ; Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 ; Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 ; Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 ; Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 ; Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 ; Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 ; Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 ; Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 ; Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 ; Service Code 2K8138 , Lot Number 160910269M , Exp. Date 6/24/2016 ; Service Code 2K8138 , Lot Number 161080325M , Exp. Date 7/11/2016 ; Service Code 2K8807 , Lot Number 160490044C , Exp. Date 5/10/2016 ; Service Code 2K8807 , Lot Number 160630012C , Exp. Date 5/24/2016 ; Service Code 2K8807 , Lot Number 160700033C , Exp. Date 5/31/2016 ; Service Code 2K8807 , Lot Number 160970033C , Exp. Date 6/27/2016 ; Service Code 2K8872 , Lot Number 160600059C , Exp. Date 5/21/2016 ; Service Code 2K8872 , Lot Number 160630026C , Exp. Date 5/24/2016 ; Service Code 2K8872 , Lot Number 160660158M , Exp. Date 5/27/2016 ; Service Code 2K8872 , Lot Number 160740036M , Exp. Date 6/3/2016 ; Service Code 2K8872 , Lot Number 160880252M , Exp. Date 6/18/2016 ; Service Code 2K8872 , Lot Number 160940031C , Exp. Date 6/24/2016 ; Service Code 2K9138 , Lot Number 160420038C , Exp. Date 5/12/2016 ; Service Code 2K9138 , Lot Number 160460045C , Exp. Date 5/16/2016 ; Service Code 2K9138 , Lot Number 160520033C , Exp. Date 5/22/2016 ; Service Code 2K9138 , Lot Number 160530050C , Exp. Date 5/23/2016 ; Service Code 2K9138 , Lot Number 160590029C , Exp. Date 5/29/2016 ; Service Code 2K9138 , Lot Number 160600062C , Exp. Date 5/30/2016 ; Service Code 2K9138 , Lot Number 160630033C , Exp. Date 6/2/2016 ; Service Code 2K9138 , Lot Number 160670077C , Exp. Date 6/6/2016 ; Service Code 2K9138 , Lot Number 160730033C , Exp. Date 6/12/2016 ; Service Code 2K9138 , Lot Number 160770056C , Exp. Date 6/16/2016 ; Service Code 2K9138 , Lot Number 160880076C , Exp. Date 6/27/2016 ; Service Code 2K9138 , Lot Number 160910024C , Exp. Date 6/30/2016 ; Service Code 2K9138 , Lot Number 160950084C , Exp. Date 7/4/2016 ; Service Code 2K9138 , Lot Number 160960054C , Exp. Date 7/5/2016 ; Service Code 2T6257 , Lot Number 160450201M , Exp. Date 5/15/2016 ; Service Code 2T6257 , Lot Number 160620194M , Exp. Date 6/1/2016 ; Service Code 2T6257 , Lot Number 160810203M , Exp. Date 6/20/2016 ; Service Code 2T6257 , Lot Number 160820230M , Exp. Date 6/21/2016 ; Service Code 2T6257 , Lot Number 160870153M , Exp. Date 6/26/2016 ; Service Code 2T6257 , Lot Number 160880278M , Exp. Date 6/27/2016 ; Service Code 2T6257 , Lot Number 160950233M , Exp. Date 7/4/2016 ; Service Code 2T8141 , Lot Number 160450016C , Exp. Date 5/6/2016 ; Service Code 2T8141 , Lot Number 160520016C , Exp. Date 5/13/2016 ; Service Code 2T8141 , Lot Number 160530019C , Exp. Date 5/14/2016 ; Service Code 2T8141 , Lot Number 160590009C , Exp. Date 5/20/2016 ; Service Code 2T8141 , Lot Number 160670022C , Exp. Date 5/28/2016 ; Service Code 2T8141 , Lot Number 160730011C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160740029C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160800022C , Exp. Date 6/10/2016 ; Service Code 2T8141 , Lot Number 160870008C , Exp. Date 6/17/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1411-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1411-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 212 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Exp. Date 5/20/2016 ; Lot Number 160740144M , Exp. Date 5/20/2016 ; Lot Number 160800152M , Exp. Date 5/27/2016 ; Lot Number 160900142M , Exp. Date 6/5/2016 ; Lot Number 160910123M , Exp. Date 6/6/2016 ; Lot Number 160940037M , Exp. Date 6/9/2016 ; Lot Number 161080048M , Exp. Date 6/24/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1389-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1389-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 425 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160390174M , Exp. Date 5/9/2016 ; Lot Number 160400196M , Exp. Date 5/10/2016 ; Lot Number 160470128M , Exp. Date 5/17/2016 ; Lot Number 160530287M , Exp. Date 5/23/2016 ; Lot Number 160540190M , Exp. Date 5/24/2016 ; Lot Number 160590168M , Exp. Date 5/29/2016 ; Lot Number 160610129M , Exp. Date 5/31/2016 ; Lot Number 160680254M , Exp. Date 6/7/2016 ; Lot Number 160700199M , Exp. Date 6/9/2016 ; Lot Number 160750132M , Exp. Date 6/14/2016 ; Lot Number 160770177M , Exp. Date 6/16/2016 ; Lot Number 160810292M , Exp. Date 6/20/2016 ; Lot Number 160820115M , Exp. Date 6/21/2016 ; Lot Number 160840157M , Exp. Date 6/23/2016 ; Lot Number 160880249M , Exp. Date 6/27/2016 ; Lot Number 160890261M , Exp. Date 6/28/2016 ; Lot Number 160940057M , Exp. Date 7/2/2016 ; Lot Number 160960151M , Exp. Date 7/5/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1409-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1409-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 435 Monoject Syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1360-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1360-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 177 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot # 160410097M; Exp. 05/16 Lot # 160420107M; Exp. 05/16 Lot # 160460117M; Exp. 05/16 Lot # 160530133M; Exp. 05/16 Lot # 160540206M; Exp. 05/16 Lot # 160570008M; Exp. 05/16 Lot # 160670132M; Exp. 06/16 Lot # 160700001C; Exp. 06/16 Lot # 160770020C; Exp. 06/16 Lot # 160900103C; Exp. 06/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1365-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1365-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 8,581 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 ; Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 ; Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 ; Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 ; Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 ; Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 ; Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 ; Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 ; Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 ; Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 ; Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 ; Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 ; Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 ; Service Code 2H8194 , Lot Number 160590170M , Exp. Date 5/29/2016 ; Service Code 2H8194 , Lot Number 160630202M , Exp. Date 6/2/2016 ; Service Code 2H8194 , Lot Number 160660049M , Exp. Date 6/4/2016 ; Service Code 2H8194 , Lot Number 160740150M , Exp. Date 6/13/2016 ; Service Code 2H8194 , Lot Number 160750224M , Exp. Date 6/14/2016 ; Service Code 2H8194 , Lot Number 160760187M , Exp. Date 6/15/2016 ; Service Code 2H8194 , Lot Number 160810145M , Exp. Date 6/19/2016 ; Service Code 2H8194 , Lot Number 160840152M , Exp. Date 6/23/2016 ; Service Code 2H8194 , Lot Number 160870050M , Exp. Date 6/25/2016 ; Service Code 2H8194 , Lot Number 160880248M , Exp. Date 6/27/2016 ; Service Code 2H8194 , Lot Number 160900001M , Exp. Date 6/28/2016 ; Service Code 2H8194 , Lot Number 160910151M , Exp. Date 6/30/2016 ; Service Code 2H8194 , Lot Number 160950209M , Exp. Date 7/4/2016 ; Service Code 2H8194 , Lot Number 160960222M , Exp. Date 7/5/2016 ; Service Code 2H8194 , Lot Number 161080218M , Exp. Date 7/17/2016 ; Service Code 2K8117 , Lot Number 160390199M , Exp. Date 5/9/2016 ; Service Code 2K8117 , Lot Number 160450108M , Exp. Date 5/15/2016 ; Service Code 2K8117 , Lot Number 160530282M , Exp. Date 5/23/2016 ; Service Code 2K8117 , Lot Number 160600287M , Exp. Date 5/30/2016 ; Service Code 2K8117 , Lot Number 160670229M , Exp. Date 6/6/2016 ; Service Code 2K8117 , Lot Number 160730046M , Exp. Date 6/11/2016 ; Service Code 2K8117 , Lot Number 160880218M , Exp. Date 6/27/2016 ; Service Code 2K8117 , Lot Number 160950211M , Exp. Date 7/4/2016 ; Service Code 2K8169 , Lot Number 160380140M , Exp. Date 5/8/2016 ; Service Code 2K8169 , Lot Number 160540205M , Exp. Date 5/24/2016 ; Service Code 2K8169 , Lot Number 160550192M , Exp. Date 5/25/2016 ; Service Code 2K8169 , Lot Number 160600071M , Exp. Date 5/30/2016 ; Service Code 2K8169 , Lot Number 160750182M , Exp. Date 6/14/2016 ; Service Code 2K8169 , Lot Number 160820048M , Exp. Date 6/20/2016 ; Service Code 2K8169 , Lot Number 160950042M , Exp. Date 7/3/2016 ; Service Code 2K8191 , Lot Number 160450060M , Exp. Date 5/14/2016 ; Service Code 2K8191 , Lot Number 160520050M , Exp. Date 5/21/2016 ; Service Code 2K8191 , Lot Number 160590082M , Exp. Date 5/29/2016 ; Service Code 2K8191 , Lot Number 160660148M , Exp. Date 6/5/2016 ; Service Code 2K8191 , Lot Number 160740190M , Exp. Date 6/13/2016 ; Service Code 2K8191 , Lot Number 160770248M , Exp. Date 6/16/2016 ; Service Code 2K8191 , Lot Number 160840226M , Exp. Date 6/23/2016 ; Service Code 2K8191 , Lot Number 160890194M , Exp. Date 6/28/2016 ; Service Code 2K8191 , Lot Number 160940236M , Exp. Date 7/3/2016 ; Service Code 2K8192 , Lot Number 160380092M , Exp. Date 5/8/2016 ; Service Code 2K8192 , Lot Number 160410238M , Exp. Date 5/11/2016 ; Service Code 2K8192 , Lot Number 160450076M , Exp. Date 5/15/2016 ; Service Code 2K8192 , Lot Number 160490050M , Exp. Date 5/19/2016 ; Service Code 2K8192 , Lot Number 160550039M , Exp. Date 5/25/2016 ; Service Code 2K8192 , Lot Number 160560317M , Exp. Date 5/26/2016 ; Service Code 2K8192 , Lot Number 160610063M , Exp. Date 5/31/2016 ; Service Code 2K8192 , Lot Number 160620324M , Exp. Date 6/1/2016 ; Service Code 2K8192 , Lot Number 160690057M , Exp. Date 6/8/2016 ; Service Code 2K8192 , Lot Number 160750125M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160750126M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160810039M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160810239M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160840048M , Exp. Date 6/23/2016 ; Service Code 2K8192 , Lot Number 160870337M , Exp. Date 6/26/2016 ; Service Code 2K8192 , Lot Number 160910053M , Exp. Date 6/30/2016 ; Service Code 2K8192 , Lot Number 160950331M , Exp. Date 7/4/2016 ; Service Code 2K8192 , Lot Number 160970298M , Exp. Date 7/6/2016 ; Service Code 2K8294 , Lot Number 160390214M , Exp. Date 5/9/2016 ; Service Code 2K8294 , Lot Number 160420153M , Exp. Date 5/11/2016 ; Service Code 2K8294 , Lot Number 160470179M , Exp. Date 5/17/2016 ; Service Code 2K8294 , Lot Number 160480224M , Exp. Date 5/18/2016 ; Service Code 2K8294 , Lot Number 160540201M , Exp. Date 5/24/2016 ; Service Code 2K8294 , Lot Number 160550225M , Exp. Date 5/25/2016 ; Service Code 2K8294 , Lot Number 160610240M , Exp. Date 5/31/2016 ; Service Code 2K8294 , Lot Number 160620116M , Exp. Date 6/1/2016 ; Service Code 2K8294 , Lot Number 160670192M , Exp. Date 6/6/2016 ; Service Code 2K8294 , Lot Number 160730159M , Exp. Date 6/12/2016 ; Service Code 2K8294 , Lot Number 160740236M , Exp. Date 6/13/2016 ; Service Code 2K8294 , Lot Number 160750217M , Exp. Date 6/14/2016 ; Service Code 2K8294 , Lot Number 160760191M , Exp. Date 6/15/2016 ; Service Code 2K8294 , Lot Number 160810209M , Exp. Date 6/20/2016 ; Service Code 2K8294 , Lot Number 160820204M , Exp. Date 6/21/2016 ; Service Code 2K8294 , Lot Number 160830177M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160840105M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160900165M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160910116M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160960226M , Exp. Date 7/5/2016 ; Service Code 2K8294 , Lot Number 161080230M , Exp. Date 7/17/2016 ; Service Code 2K8829 , Lot Number 160600054C , Exp. Date 5/9/2016 ; Service Code 2K8829 , Lot Number 160620028C , Exp. Date 5/11/2016 ; Service Code 2K8829 , Lot Number 160670050C , Exp. Date 5/16/2016 ; Service Code 2K8829 , Lot Number 160680048C , Exp. Date 5/17/2016 ; Service Code 2K8829 , Lot Number 160740061C , Exp. Date 5/23/2016 ; Service Code 2K8829 , Lot Number 160810072C , Exp. Date 5/30/2016 ; Service Code 2K8829 , Lot Number 160870029C , Exp. Date 6/5/2016 ; Service Code 2K8829 , Lot Number 160950049C , Exp. Date 6/13/2016 ; Service Code 2K8881 , Lot Number 160670060C , Exp. Date 5/16/2016 ; Service Code 2K8881 , Lot Number 160740062C , Exp. Date 5/23/2016 ; Service Code 2K8881 , Lot Number 160810068C , Exp. Date 5/30/2016 ; Service Code 2K8881 , Lot Number 160880036C , Exp. Date 6/6/2016 ; Service Code 2K8881 , Lot Number 160910019C , Exp. Date 6/9/2016 ; Service Code 2K8881 , Lot Number 160950074C , Exp. Date 6/13/2016 ; Service Code 2K8882 , Lot Number 160620027C , Exp. Date 5/11/2016 ; Service Code 2K8882 , Lot Number 160760043C , Exp. Date 5/25/2016 ; Service Code 2K8882 , Lot Number 160810075C , Exp. Date 5/30/2016 ; Service Code 2K8882 , Lot Number 160830062C , Exp. Date 6/1/2016 ; Service Code 2K8882 , Lot Number 160880071C , Exp. Date 6/6/2016 ; Service Code 2K8882 , Lot Number 160900112C , Exp. Date 6/8/2016 ; Service Code 2K8930 , Lot Number 160970150M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 160970151M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 161080317M , Exp. Date 5/18/2016 ; Service Code 2N1117 , Lot Number 160420020C , Exp. Date 5/12/2016 ; Service Code 2N1117 , Lot Number 160470032C , Exp. Date 5/17/2016 ; Service Code 2N1117 , Lot Number 160550028C , Exp. Date 5/25/2016 ; Service Code 2N1117 , Lot Number 160680029C , Exp. Date 6/7/2016 ; Service Code 2N1117 , Lot Number 160770039C , Exp. Date 6/16/2016 ; Service Code 2N1117 , Lot Number 160830043C , Exp. Date 6/22/2016 ; Service Code 2N1117 , Lot Number 160880056C , Exp. Date 6/27/2016 ; Service Code 2N1117 , Lot Number 160960026C , Exp. Date 7/5/2016 ; Service Code 2N1192 , Lot Number 160400192M , Exp. Date 5/10/2016 ; Service Code 2N1192 , Lot Number 160480196M , Exp. Date 5/18/2016 ; Service Code 2N1192 , Lot Number 160550005M , Exp. Date 5/24/2016 ; Service Code 2N1192 , Lot Number 160550118M , Exp. Date 5/25/2016 ; Service Code 2N1192 , Lot Number 160560204M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160570006M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160590060M , Exp. Date 5/29/2016 ; Service Code 2N1192 , Lot Number 160690038M , Exp. Date 6/7/2016 ; Service Code 2N1192 , Lot Number 160800071M , Exp. Date 6/18/2016 ; Service Code 2N1192 , Lot Number 160830047M , Exp. Date 6/21/2016 ; Service Code 2N1192 , Lot Number 160900125M , Exp. Date 6/28/2016 ; Service Code 2N1192 , Lot Number 160910122M , Exp. Date 6/29/2016 ; Service Code 2N1918 , Lot Number 160960017C , Exp. Date 5/6/2016 ; Service Code 2N1918 , Lot Number 160970017C , Exp. Date 5/7/2016 ; Service Code 3V8719 , Lot Number 160420031C , Exp. Date 5/12/2016 ; Service Code 3V8719 , Lot Number 160480039C , Exp. Date 5/18/2016 ; Service Code 3V8719 , Lot Number 160540029C , Exp. Date 5/24/2016 ; Service Code 3V8719 , Lot Number 160610038C , Exp. Date 5/31/2016 ; Service Code 3V8719 , Lot Number 160700003C , Exp. Date 6/9/2016 ; Service Code 3V8719 , Lot Number 160760033C , Exp. Date 6/15/2016 ; Service Code 3V8719 , Lot Number 160830047C , Exp. Date 6/22/2016 ; Service Code 3V8719 , Lot Number 160900111C , Exp. Date 6/29/2016 ; Service Code 3V8719 , Lot Number 160970031C , Exp. Date 7/6/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1366-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1366-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 315 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1381-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1381-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 600 Monoject Syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1390-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1390-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 60 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160390213M , Exp. Date 5/9/2016 ; Lot Number 160420162M , Exp. Date 5/12/2016 ; Lot Number 160480197M , Exp. Date 5/18/2016 ; Lot Number 160600057M , Exp. Date 5/29/2016 ; Lot Number 161080145M , Exp. Date 7/17/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1416-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1416-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5,727 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 3V8708 , Lot Number 160410168M , Exp. Date 5/11/2016 ; Service Code 3V8708 , Lot Number 160600286M , Exp. Date 5/30/2016 ; Service Code 3V8708 , Lot Number 160810284M , Exp. Date 6/20/2016 ; Service Code 3V8708 , Lot Number 160820091M , Exp. Date 6/20/2016 ; Service Code 2H8285 , Lot Number 160470170M , Exp. Date 5/13/2016 ; Service Code 2H8285 , Lot Number 160530182M , Exp. Date 5/19/2016 ; Service Code 2H8285 , Lot Number 160600296M , Exp. Date 5/26/2016 ; Service Code 2H8285 , Lot Number 160670185M , Exp. Date 6/2/2016 ; Service Code 2H8285 , Lot Number 160740253M , Exp. Date 6/9/2016 ; Service Code 2H8285 , Lot Number 160820206M , Exp. Date 6/17/2016 ; Service Code 2H8285 , Lot Number 160880254M , Exp. Date 6/23/2016 ; Service Code 2H8285 , Lot Number 160910152M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160400261M , Exp. Date 5/10/2016 ; Service Code 2K8237 , Lot Number 160450263M , Exp. Date 5/15/2016 ; Service Code 2K8237 , Lot Number 160540239M , Exp. Date 5/24/2016 ; Service Code 2K8237 , Lot Number 160620203M , Exp. Date 6/1/2016 ; Service Code 2K8237 , Lot Number 160700152M , Exp. Date 6/9/2016 ; Service Code 2K8237 , Lot Number 160730269M , Exp. Date 6/12/2016 ; Service Code 2K8237 , Lot Number 160760207M , Exp. Date 6/15/2016 ; Service Code 2K8237 , Lot Number 160810315M , Exp. Date 6/20/2016 ; Service Code 2K8237 , Lot Number 160870248M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160940250M , Exp. Date 7/3/2016 ; Service Code 2K8237 , Lot Number 160970220M , Exp. Date 7/6/2016 ; Service Code 2K8643 , Lot Number 160420245M , Exp. Date 5/12/2016 ; Service Code 2K8643 , Lot Number 160470238M , Exp. Date 5/17/2016 ; Service Code 2K8643 , Lot Number 160480261M , Exp. Date 5/18/2016 ; Service Code 2K8643 , Lot Number 160600351M , Exp. Date 5/30/2016 ; Service Code 2K8643 , Lot Number 160700177M , Exp. Date 6/9/2016 ; Service Code 2K8643 , Lot Number 160770260M , Exp. Date 6/16/2016 ; Service Code 2K8643 , Lot Number 160870191M , Exp. Date 6/26/2016 ; Service Code 2K8643 , Lot Number 160910247M , Exp. Date 6/30/2016 ; Service Code 2K8643 , Lot Number 161080279M , Exp. Date 7/17/2016 ; Service Code 2K8837 , Lot Number 160460262M , Exp. Date 5/7/2016 ; Service Code 2K8837 , Lot Number 160530235M , Exp. Date 5/14/2016 ; Service Code 2K8837 , Lot Number 160600335M , Exp. Date 5/21/2016 ; Service Code 2K8837 , Lot Number 160630109M , Exp. Date 5/24/2016 ; Service Code 2K8837 , Lot Number 160740138M , Exp. Date 6/4/2016 ; Service Code 2K8837 , Lot Number 160770249M , Exp. Date 6/7/2016 ; Service Code 2K8837 , Lot Number 160870243M , Exp. Date 6/17/2016 ; Service Code 2K8837 , Lot Number 160880159M , Exp. Date 6/18/2016 ; Service Code 2K8837 , Lot Number 160900184M , Exp. Date 6/20/2016 ; Service Code 2K8837 , Lot Number 160960129M , Exp. Date 6/26/2016 ; Service Code 2K8906 , Lot Number 160480019M , Exp. Date 5/9/2016 ; Service Code 2K8906 , Lot Number 160540174M , Exp. Date 5/15/2016 ; Service Code 2K8906 , Lot Number 160610163M , Exp. Date 5/22/2016 ; Service Code 2K8906 , Lot Number 160700148M , Exp. Date 5/31/2016 ; Service Code 2K8906 , Lot Number 160750221M , Exp. Date 6/5/2016 ; Service Code 2K8906 , Lot Number 160770136M , Exp. Date 6/7/2016 ; Service Code 2K8906 , Lot Number 160820127M , Exp. Date 6/12/2016 ; Service Code 2K8906 , Lot Number 160890210M , Exp. Date 6/19/2016 ; Service Code 2K8906 , Lot Number 160960171M , Exp. Date 6/26/2016 ; Service Code 2K8963 , Lot Number 160550244M , Exp. Date 5/16/2016 ; Service Code 2K8963 , Lot Number 160560180M , Exp. Date 5/17/2016 ; Service Code 2K8963 , Lot Number 160670202M , Exp. Date 5/28/2016 ; Service Code 2K8963 , Lot Number 160750055C , Exp. Date 6/5/2016 ; Service Code 2K8963 , Lot Number 160760031C , Exp. Date 6/6/2016 ; Service Code 2K8963 , Lot Number 160810065C , Exp. Date 6/11/2016 ; Service Code 2K8963 , Lot Number 160820057C , Exp. Date 6/12/2016 ; Service Code 2K8963 , Lot Number 160890042C , Exp. Date 6/19/2016 ; Service Code 2K8963 , Lot Number 160950052C , Exp. Date 6/25/2016 ; Service Code 2K8963 , Lot Number 160950187M , Exp. Date 6/25/2016 ; Service Code 2K8976 , Lot Number 160470034C , Exp. Date 5/8/2016 ; Service Code 2K8976 , Lot Number 160840015C , Exp. Date 6/14/2016 ; Service Code 2K8976 , Lot Number 160880064C , Exp. Date 6/18/2016 ; Service Code 2K9285 , Lot Number 160450032C , Exp. Date 5/9/2016 ; Service Code 2K9285 , Lot Number 160520065C , Exp. Date 5/16/2016 ; Service Code 2K9285 , Lot Number 160630020C , Exp. Date 5/27/2016 ; Service Code 2K9285 , Lot Number 160690030C , Exp. Date 6/2/2016 ; Service Code 2K9285 , Lot Number 160770036C , Exp. Date 6/10/2016 ; Service Code 2K9285 , Lot Number 160840031C , Exp. Date 6/17/2016 ; Service Code 2K9285 , Lot Number 160880075C , Exp. Date 6/21/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1424-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1424-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 562 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1370-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1370-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 161080149M; Exp. Date 5/18/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1434-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1434-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 650 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160390094M , Exp. Date 5/9/2016 ; Lot Number 160450111M , Exp. Date 5/15/2016 ; Lot Number 160520101M , Exp. Date 5/22/2016 ; Lot Number 160550109M , Exp. Date 5/25/2016 ; Lot Number 160610124M , Exp. Date 5/31/2016 ; Lot Number 160620115M , Exp. Date 6/1/2016 ; Lot Number 160670036M , Exp. Date 6/5/2016 ; Lot Number 160680038M , Exp. Date 6/7/2016 ; Lot Number 160690110M , Exp. Date 6/7/2016 ; Lot Number 160740117M , Exp. Date 6/12/2016 ; Lot Number 160760109M , Exp. Date 6/15/2016 ; Lot Number 160820103M , Exp. Date 6/21/2016 ; Lot Number 160830107M , Exp. Date 6/22/2016 ; Lot Number 160900032M , Exp. Date 6/29/2016 ; Lot Number 160970021M , Exp. Date 7/6/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1377-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1377-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 384 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 ; Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 ; Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 ; Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 ; Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 ; Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 ; Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1406-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1406-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 220 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8210 , Lot Number 160390175M , Exp. Date 5/9/2016 ; Service Code 2K8210 , Lot Number 160400226M , Exp. Date 5/10/2016 ; Service Code 2K8210 , Lot Number 160520170M , Exp. Date 5/22/2016 ; Service Code 2K8210 , Lot Number 160590066M , Exp. Date 5/29/2016 ; Service Code 2K8210 , Lot Number 160670046M , Exp. Date 6/5/2016 ; Service Code 2K8210 , Lot Number 160680006M , Exp. Date 6/6/2016 ; Service Code 2K8210 , Lot Number 160700027M , Exp. Date 6/8/2016 ; Service Code 2K8210 , Lot Number 160730069M , Exp. Date 6/11/2016 ; Service Code 2K8210 , Lot Number 160880217M , Exp. Date 6/27/2016 ; Service Code 2K8972 , Lot Number 160450177M , Exp. Date 5/6/2016 ; Service Code 2K8972 , Lot Number 160460196M , Exp. Date 5/7/2016 ; Service Code 2K8972 , Lot Number 160600082M , Exp. Date 5/20/2016 ; Service Code 2K8972 , Lot Number 160670061C , Exp. Date 5/28/2016 ; Service Code 2K8972 , Lot Number 160740067C , Exp. Date 6/4/2016 ; Service Code 2K8972 , Lot Number 160810085C , Exp. Date 6/11/2016 ; Service Code 2K8972 , Lot Number 160950188M , Exp. Date 6/25/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1428-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1428-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 115 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Exp. Date 5/24/2016 ; Lot Number 160660046M , Exp. Date 6/4/2016 ; Lot Number 160730154M , Exp. Date 6/12/2016 ; Lot Number 160750176M , Exp. Date 6/14/2016 ; Lot Number 160760046M , Exp. Date 6/14/2016 ; Lot Number 160800066M , Exp. Date 6/18/2016 ; Lot Number 160820111M , Exp. Date 6/20/2016 ; Lot Number 160960039M , Exp. Date 7/4/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1398-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1398-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 940 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/2016 ; Lot Number 160730238M , Exp. Date 6/12/2016 ; Lot Number 160840215M , Exp. Date 6/23/2016 ; Lot Number 160880193M , Exp. Date 6/27/2016 ; Lot Number 160890187M , Exp. Date 6/28/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1433-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1433-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 79 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160450146M , Exp. Date 5/14/2016 ; Lot Number 160520168M , Exp. Date 5/22/2016 ; Lot Number 160620181M , Exp. Date 6/1/2016 ; Lot Number 160760038M , Exp. Date 6/14/2016 ; Lot Number 160900172M , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1431-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1431-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160540183M , Exp. Date 5/23/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1382-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1382-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 740 BD syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1417-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1417-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,015 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160390336M , Exp. Date 5/9/2016 ; Lot Number 160530318M , Exp. Date 5/23/2016 ; Lot Number 160600347M , Exp. Date 5/30/2016 ; Lot Number 160750243M , Exp. Date 6/14/2016 ; Lot Number 160760164M , Exp. Date 6/14/2016 ; Lot Number 160830228M , Exp. Date 6/22/2016 ; Lot Number 160890224M , Exp. Date 6/28/2016 ; Lot Number 160960242M , Exp. Date 7/5/2016 ; Lot Number 160970140M , Exp. Date 7/6/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1373-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1373-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 40 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160630037M , Exp. Date 5/23/2016 ; Lot Number 160640007M , Exp. Date 5/24/2016 ; Lot Number 160700207M , Exp. Date 5/31/2016 ; Lot Number 160730149M , Exp. Date 6/3/2016 ; Lot Number 160830163M , Exp. Date 6/12/2016 ; Lot Number 160880258M , Exp. Date 6/18/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1393-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1393-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,476 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 ; Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 ; Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 ; Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 ; Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 ; Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 ; Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 ; Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 ; Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 ; Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 ; Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 ; Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 ; Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 ; Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 ; Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 ; Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 ; Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 ; Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 ; Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 ; Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 ; Service Code 2T6296 , Lot Number 160530159M , Exp. Date 5/23/2016 ; Service Code 2T6296 , Lot Number 160690195M , Exp. Date 6/8/2016 ; Service Code 2T6296 , Lot Number 160750219M , Exp. Date 6/14/2016 ; Service Code 2T6296 , Lot Number 160810166M , Exp. Date 6/20/2016 ; Service Code 2T6296 , Lot Number 160880176M , Exp. Date 6/26/2016 ; Service Code 2T6296 , Lot Number 160940048M , Exp. Date 7/2/2016 ; Service Code 2T6296 , Lot Number 160970123M , Exp. Date 7/5/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1394-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1394-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,280 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092001C , Exp. Date 6/21/2016 ; Service Code 2T8871 , Lot Number 160970026M , Exp. Date 5/7/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1405-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1405-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,006 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 ; Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 ; Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 ; Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 ; Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 ; Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 ; Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 ; Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 ; Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 ; Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 ; Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 ; Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 ; Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 ; Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 ; Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 ; Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 ; Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 ; Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 ; Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 ; Service Code 2T8255 , Lot Number 160700030C , Exp. Date 5/30/2016 ; Service Code 2T8255 , Lot Number 160700031C , Exp. Date 5/31/2016 ; Service Code 2T8255 , Lot Number 160740060C , Exp. Date 6/4/2016 ; Service Code 2T8255 , Lot Number 160770034C , Exp. Date 6/7/2016 ; Service Code 2T8255 , Lot Number 160830059C , Exp. Date 6/13/2016 ; Service Code 2T8255 , Lot Number 160880040C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160880041C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160940029C , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160950051C , Exp. Date 6/25/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1387-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1387-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,277 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8482 , Lot Number 160400113M , Exp. Date 5/10/2016 ; Service Code 2K8482 , Lot Number 160460097M , Exp. Date 5/16/2016 ; Service Code 2K8482 , Lot Number 160470229M , Exp. Date 5/17/2016 ; Service Code 2K8482 , Lot Number 160530109M , Exp. Date 5/23/2016 ; Service Code 2K8482 , Lot Number 160630133M , Exp. Date 6/2/2016 ; Service Code 2K8482 , Lot Number 160670166M , Exp. Date 6/6/2016 ; Service Code 2K8482 , Lot Number 160680146M , Exp. Date 6/7/2016 ; Service Code 2K8482 , Lot Number 160750150M , Exp. Date 6/14/2016 ; Service Code 2K8482 , Lot Number 160810139M , Exp. Date 6/20/2016 ; Service Code 2K8482 , Lot Number 160910246M , Exp. Date 6/30/2016 ; Service Code 2K8482 , Lot Number 160960036C , Exp. Date 7/5/2016 ; Service Code 2K8482 , Lot Number 160970147M , Exp. Date 7/6/2016 ; Service Code 2K8482 , Lot Number 161080277M , Exp. Date 7/17/2016 ; Service Code 2K8908 , Lot Number 160940041C , Exp. Date 5/10/2016 ; Service Code 2K8908 , Lot Number 160950030C , Exp. Date 5/11/2016 ; Service Code 2T6482 , Lot Number 160560209M , Exp. Date 5/26/2016 ; Service Code 2T6482 , Lot Number 160590158M , Exp. Date 5/29/2016 ; Service Code 2T6482 , Lot Number 160750214M , Exp. Date 6/14/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1432-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1432-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 180 syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1386-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1386-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,234 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160610237M , Exp. Date 5/31/2016 ; Service Code 2K8481 , Lot Number 160630118M , Exp. Date 6/2/2016 ; Service Code 2K8481 , Lot Number 160660175M , Exp. Date 6/5/2016 ; Service Code 2K8481 , Lot Number 160670245M , Exp. Date 6/6/2016 ; Service Code 2K8481 , Lot Number 160730063M , Exp. Date 6/12/2016 ; Service Code 2K8481 , Lot Number 160770227M , Exp. Date 6/16/2016 ; Service Code 2K8481 , Lot Number 160840171M , Exp. Date 6/23/2016 ; Service Code 2K8481 , Lot Number 160870146M , Exp. Date 6/26/2016 ; Service Code 2K8481 , Lot Number 160910219M , Exp. Date 6/30/2016 ; Service Code 2K8481 , Lot Number 160940163M , Exp. Date 7/3/2016 ; Service Code 2K8481 , Lot Number 160970137M , Exp. Date 7/6/2016 ; Service Code 2K8481 , Lot Number 161080124M , Exp. Date 7/17/2016 ; Service Code 2K8909 , Lot Number 160910236M , Exp. Date 5/7/2016 ; Service Code 2K8909 , Lot Number 160950070C , Exp. Date 5/11/2016 ; Service Code 2K8909 , Lot Number 161080282M , Exp. Date 5/24/2016 ; Service Code 2K8911 , Lot Number 160970035M , Exp. Date 5/6/2016 ; Service Code 2T6481 , Lot Number 160590144M , Exp. Date 5/29/2016 ; Service Code 2T6481 , Lot Number 160610031M , Exp. Date 5/31/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1361-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1361-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 80 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot # 160420165M; Exp. 05/16 Lot # 160540128M; Exp. 05/16 Lot # 160630117M; Exp. 06/16 Lot # 160770157M; Exp. 06/16 Lot # 160870055M; Exp. 06/16 Lot # 160890153M; Exp. 06/16 Lot # 160950340M; Exp. 07/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1413-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1413-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 700 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160420248M , Exp. Date 5/6/2016 ; Lot Number 160490250M , Exp. Date 5/13/2016 ; Lot Number 160600329M , Exp. Date 5/24/2016 ; Lot Number 160620002M , Exp. Date 5/25/2016 ; Lot Number 160660181M , Exp. Date 5/30/2016 ; Lot Number 160760025M , Exp. Date 6/9/2016 ; Lot Number 160870159M , Exp. Date 6/20/2016 ; Lot Number 160940170M , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1427-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1427-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 45 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160500008M , Exp. Date 5/10/2016 ; Lot Number 160940038C , Exp. Date 6/24/2016 ; Lot Number 160970126M , Exp. Date 6/27/2016 ; Lot Number 161080140M , Exp. Date 7/8/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1397-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1397-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 250 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160470226M , Exp. Date 5/11/2016 ; Lot Number 160540237M , Exp. Date 5/18/2016 ; Lot Number 160600045M , Exp. Date 5/23/2016 ; Lot Number 160750052M , Exp. Date 6/7/2016 ; Lot Number 160950043M , Exp. Date 6/27/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1418-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1418-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 455 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1385-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1385-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 30 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot # 160890042M; Exp. Date 5/13/2016 Lot # 160960052M; Exp. Date 5/20/2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1421-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1421-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,256 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1408-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1408-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot # 160630032M; Exp. 6/1/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1388-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1388-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 230 BD syringes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160410126M , Exp. Date 5/10/2016 ; Lot Number 160450114M , Exp. Date 5/14/2016 ; Lot Number 160460158M , Exp. Date 5/15/2016 ; Lot Number 160670040M , Exp. Date 6/5/2016 ; Lot Number 160730148M , Exp. Date 6/12/2016 ; Lot Number 160840112M , Exp. Date 6/22/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1362-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1362-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,194 bags and cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1404-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1404-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 85 Medical Cassettes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Service Code 2K8892 , Lot Number 160560168M , Exp. Date 5/17/2016 ; Service Code 2K8892 , Lot Number 160810001M , Exp. Date 6/10/2016 ; Service Code 2K8219 , Lot Number 160530297M , Exp. Date 5/23/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1410-2016
- Event ID
- 74057 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1410-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61
- Reason For Recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 25 bags Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 05-05-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-06-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Pharmedium Services, LLC
- Code Info
- Lot Number 160530134M , Exp. Date 5/23/2016 ; Lot Number 160630039M , Exp. Date 6/1/2016 ; Lot Number 160900044M , Exp. Date 6/28/2016 ; Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
