Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1430-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 90 bags | Class II | Terminated |
| D-1422-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 655 bags | Class II | Terminated |
| D-1400-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 480 bags | Class II | Terminated |
| D-1402-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 95 bags | Class II | Terminated |
| D-1399-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 21 Medical Cassettes | Class II | Terminated |
| D-1383-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 55 bags | Class II | Terminated |
| D-1419-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 3,828 syringes | Class II | Terminated |
| D-1395-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 43,589 bags | Class II | Terminated |
| D-1426-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 3,927 syringes | Class II | Terminated |
| D-1365-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 8,581 bags | Class II | Terminated |
| D-1396-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 97,716 bags | Class II | Terminated |
| D-1378-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 65 bags | Class II | Terminated |
| D-1420-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 936 Medical Cassettes | Class II | Terminated |
| D-1360-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 177 Medical Cassettes | Class II | Terminated |
| D-1409-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 435 Monoject Syringes | Class II | Terminated |
| D-1390-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 60 bags | Class II | Terminated |
| D-1416-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 5,727 Medical Cassettes | Class II | Terminated |
| D-1366-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 315 Medical Cassettes | Class II | Terminated |
| D-1424-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 562 bags | Class II | Terminated |
| D-1381-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 600 Monoject Syringes | Class II | Terminated |
| D-1406-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 220 Medical Cassettes | Class II | Terminated |
| D-1377-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 384 Medical Cassettes | Class II | Terminated |
| D-1428-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 115 bags | Class II | Terminated |
| D-1434-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 650 bags | Class II | Terminated |
| D-1370-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 10 bags | Class II | Terminated |
| D-1405-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 2,006 bags | Class II | Terminated |
| D-1387-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,277 bags | Class II | Terminated |
| D-1432-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 180 syringes | Class II | Terminated |
| D-1393-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,476 bags | Class II | Terminated |
| D-1394-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,280 Medical Cassettes | Class II | Terminated |
| D-1382-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 740 BD syringes | Class II | Terminated |
| D-1417-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,015 bags | Class II | Terminated |
| D-1373-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 40 Medical Cassettes | Class II | Terminated |
| D-1433-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 79 syringes | Class II | Terminated |
| D-1431-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 5 syringes | Class II | Terminated |
| D-1398-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 940 bags | Class II | Terminated |
| D-1386-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,234 Medical Cassettes | Class II | Terminated |
| D-1361-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 80 bags | Class II | Terminated |
| D-1413-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 700 bags | Class II | Terminated |
| D-1427-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 45 Medical Cassettes | Class II | Terminated |
| D-1397-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 250 bags | Class II | Terminated |
| D-1418-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 455 bags | Class II | Terminated |
| D-1057-2016 | 05-05-2016 | Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03 | Discoloration: presence of scuffing marks on tablets. | KVK-Tech, Inc. / 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A | Class III | Terminated |
| D-1388-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 230 BD syringes | Class II | Terminated |
| D-1408-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 10 bags | Class II | Terminated |
| D-1385-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 30 bags | Class II | Terminated |
| D-1421-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 2,256 Medical Cassettes | Class II | Terminated |
| D-1410-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 25 bags | Class II | Terminated |
| D-1362-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 2,194 bags and cassettes | Class II | Terminated |
| D-1404-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 85 Medical Cassettes | Class II | Terminated |
| D-0867-2016 | 05-04-2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04 | Failed Impuities/Degradation Specifications | Fresenius Kabi USA, LLC / 40,280 vials | Class II | Terminated |
| D-0866-2016 | 05-04-2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01. | Failed Impuities/Degradation Specifications | Fresenius Kabi USA, LLC / 355,150 vials | Class II | Terminated |
| D-1045-2016 | 05-02-2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01 | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. | Sandoz, Inc / 78,606 bottles | Class III | Terminated |
| D-1046-2016 | 05-02-2016 | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01 | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. | Sandoz, Inc / N/A | Class III | Terminated |
| D-0222-2017 | 04-29-2016 | 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. | Making It a Lifestyle / 1000 bottles | Class II | Terminated |
| D-0220-2017 | 04-29-2016 | BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. | Making It a Lifestyle / 1000 bottles | Class I | Terminated |
| D-0221-2017 | 04-29-2016 | BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. | Making It a Lifestyle / 1000 bottles | Class I | Terminated |
| D-0858-2016 | 04-28-2016 | Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30 | Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered. | Lymol Medical / 25,007 canisters | Class II | Terminated |
| D-0857-2016 | 04-28-2016 | Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30. | Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. | Pfizer Inc. / 68, 214 bottles | Class II | Terminated |
| D-0956-2016 | 04-27-2016 | Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 Package NDCs: 0169-7704-21; 0169-7704-92; 0169-7705-21; 0169-7705-92; 0169-7708-21; 0169-7708-92; 0169-7703-11; 0169-7703-91; 0169-7703-21; 0169-7703-92 | Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step | Novo Nordisk Inc / 723 pens | Class II | Terminated |
| D-1029-2016 | 04-27-2016 | Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1 | Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial. | Genzyme Corporation / Genzyme Biosurgery / 2350 vials | Class III | Terminated |
| D-0868-2016 | 04-27-2016 | Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 | Lack of Assurance of Sterility: Due to potential for leaking bags. | Teva North America / 546 bags | Class II | Terminated |
| D-1037-2016 | 04-25-2016 | Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37 Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Presence of Particulate Matter: Glass particulate found in sterile injectable product | Fresenius Kabi USA, LLC / 69225 units | Class II | Terminated |
| D-1058-2016 | 04-22-2016 | CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523 | Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP. | Dr. Reddy's Laboratories, Inc. / 84,240 bottles | Class III | Terminated |
| D-0839-2016 | 04-22-2016 | Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0 | Labeling: Not elsewhere classified - count on the label was incorrect. | A-S Medication Solutions LLC. / 2730 bottles | Class III | Terminated |
| D-1316-2016 | 04-20-2016 | Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 300 | Class II | Terminated |
| D-1318-2016 | 04-20-2016 | Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 216 | Class II | Terminated |
| D-1297-2016 | 04-20-2016 | Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 72 | Class II | Terminated |
| D-1301-2016 | 04-20-2016 | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1200 | Class II | Terminated |
| D-1332-2016 | 04-20-2016 | Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 50 | Class II | Terminated |
| D-1288-2016 | 04-20-2016 | Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1321-2016 | 04-20-2016 | Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 55 | Class II | Terminated |
| D-1307-2016 | 04-20-2016 | Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 30 | Class II | Terminated |
| D-1349-2016 | 04-20-2016 | CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 48 bottles | Class II | Terminated |
| D-1350-2016 | 04-20-2016 | Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 96 bottles | Class II | Terminated |
| D-1346-2016 | 04-20-2016 | ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 204 bottles | Class II | Terminated |
| D-1265-2016 | 04-20-2016 | Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 280 | Class II | Terminated |
| D-1335-2016 | 04-20-2016 | Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1675 | Class II | Terminated |
| D-1295-2016 | 04-20-2016 | Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 384 | Class II | Terminated |
| D-1282-2016 | 04-20-2016 | Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 72 | Class II | Terminated |
| D-1343-2016 | 04-20-2016 | Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 70 | Class II | Terminated |
| D-1311-2016 | 04-20-2016 | Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 250 | Class II | Terminated |
| D-1344-2016 | 04-20-2016 | Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 595 | Class II | Terminated |
| D-1334-2016 | 04-20-2016 | Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2300 | Class II | Terminated |
| D-1356-2016 | 04-20-2016 | PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 216 packets | Class II | Terminated |
| D-1354-2016 | 04-20-2016 | WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / Unknown | Class II | Terminated |
| D-1317-2016 | 04-20-2016 | Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 45 | Class II | Terminated |
| D-1270-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 105 | Class II | Terminated |
| D-1300-2016 | 04-20-2016 | Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 45 | Class II | Terminated |
| D-1278-2016 | 04-20-2016 | HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 4500 | Class II | Terminated |
| D-1322-2016 | 04-20-2016 | Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2175 | Class II | Terminated |
| D-1290-2016 | 04-20-2016 | Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 142 | Class II | Terminated |
| D-1327-2016 | 04-20-2016 | Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 800 | Class II | Terminated |
| D-1261-2016 | 04-20-2016 | Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1575 | Class II | Terminated |
| D-1347-2016 | 04-20-2016 | FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / unknown | Class II | Terminated |
| D-1264-2016 | 04-20-2016 | Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2580 | Class II | Terminated |
| D-1340-2016 | 04-20-2016 | Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 275 | Class II | Terminated |
| D-1353-2016 | 04-20-2016 | GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / Unknown | Class II | Terminated |
| D-1269-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 95 | Class II | Terminated |
| D-1263-2016 | 04-20-2016 | Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 200 | Class II | Terminated |
