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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1191-2016 | 05-13-2016 | HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 800 mL in Vials | Class II | Terminated |
| D-1252-2016 | 05-13-2016 | ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1220-2016 | 05-13-2016 | M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 187 mL in Vials | Class II | Terminated |
| D-1200-2016 | 05-13-2016 | LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 147 mL in Vials | Class II | Terminated |
| D-1206-2016 | 05-13-2016 | LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1192-2016 | 05-13-2016 | HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 7000 mL in Vials | Class II | Terminated |
| D-1237-2016 | 05-13-2016 | RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 35 mL in Vials | Class II | Terminated |
| D-1251-2016 | 05-13-2016 | ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1194-2016 | 05-13-2016 | L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1400 mL in Vials | Class II | Terminated |
| D-1228-2016 | 05-13-2016 | NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 157,500 mL in Vials | Class II | Terminated |
| D-1169-2016 | 05-13-2016 | B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 60 mL in Vials | Class II | Terminated |
| D-1222-2016 | 05-13-2016 | M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 110 mL in Vials | Class II | Terminated |
| D-1247-2016 | 05-13-2016 | THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 213 mL in Vials | Class II | Terminated |
| D-1179-2016 | 05-13-2016 | DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1110 mL in Vials | Class II | Terminated |
| D-1180-2016 | 05-13-2016 | DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1201-2016 | 05-13-2016 | LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 7000 mL in Vials | Class II | Terminated |
| D-1044-2016 | 05-13-2016 | Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10 | Chemical Contamination: Bottles may contain broken dessicants | Virtus Pharmaceuticals, Llc / 24,614 bottles | Class III | Terminated |
| D-0102-2017 | 05-12-2016 | Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0101-2017 | 05-12-2016 | Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0104-2017 | 05-12-2016 | Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0103-2017 | 05-12-2016 | Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-1042-2016 | 05-11-2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 | CGMP Deviations | Profarma Distributors LLC / 254 boxes (254 tablets) | Class II | Terminated |
| D-1041-2016 | 05-11-2016 | VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 | CGMP Deviations | Profarma Distributors LLC / 163 boxes (978 tablets) | Class II | Terminated |
| D-1043-2016 | 05-11-2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 | CGMP Deviations | Profarma Distributors LLC / 79 boxes (79 tubes) | Class II | Terminated |
| D-1039-2016 | 05-11-2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | CGMP Deviations | Profarma Distributors LLC / 42 boxes (504 capsules) | Class II | Terminated |
| D-1040-2016 | 05-11-2016 | tabcin NOCHE; Capsules,12-count box, UPC 501008485033 | CGMP Deviations | Profarma Distributors LLC / 31 boxes ( 372 capsules) | Class II | Terminated |
| D-1053-2016 | 05-11-2016 | aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089 | CGMP Deviations | The Aloe Source / 577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes) | Class II | Terminated |
| D-0977-2016 | 05-10-2016 | Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762 | Labeling; Product Contains Undeclared API (Oxybenzone) | Bayer Health Care LLC / 37,512 bottles | Class II | Terminated |
| D-1065-2016 | 05-10-2016 | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159 | Failed Content Uniformity Specifications. | Allergan Sales, LLC / N/A | Class II | Terminated |
| D-1064-2016 | 05-10-2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612 | Failed Content Uniformity Specifications. | Allergan Sales, LLC / 17802 units | Class II | Terminated |
| D-1491-2016 | 05-09-2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06 Package NDCs: 68382-110-06; 68382-110-01 | Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches. | Zydus Pharmaceuticals USA Inc / 14,808 bottles | Class II | Terminated |
| D-1033-2016 | 05-06-2016 | Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01 | Presence of Particulate Matter: Cardboard | Hospira Inc. / | Class II | Terminated |
| D-1376-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 25 bags | Class II | Terminated |
| D-1423-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 3,474 bags | Class II | Terminated |
| D-1429-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 445 bags | Class II | Terminated |
| D-1403-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 105 bags | Class II | Terminated |
| D-1375-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,527 bags | Class II | Terminated |
| D-1415-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,470 bags | Class II | Terminated |
| D-1363-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 15 bags | Class II | Terminated |
| D-1414-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 345 bags | Class II | Terminated |
| D-1367-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 355 bags | Class II | Terminated |
| D-1412-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 555 Medical Cassettes | Class II | Terminated |
| D-1364-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 4,081 bags | Class II | Terminated |
| D-1407-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 380 bags | Class II | Terminated |
| D-1372-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 866 bags | Class II | Terminated |
| D-1391-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 17,990 bags | Class II | Terminated |
| 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-1392-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 950 bags | Class II | Terminated |
| D-1374-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 361 bags | Class II | Terminated |
| D-1371-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 325 Medical Cassettes | Class II | Terminated |
| D-1384-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 1,577 BD syringes | Class II | Terminated |
| D-1379-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 750 bags | Class II | Terminated |
| D-1380-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / N/A | Class II | Terminated |
| D-1369-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 140 bags | Class II | Terminated |
| D-1368-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 2,874 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1389-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 425 bags | Class II | Terminated |
| D-1411-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 212 Medical Cassettes | Class II | Terminated |
| D-1425-206 | 05-05-2016 | 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. | Pharmedium Services, LLC / 2,713 syringes | Class II | Terminated |
| D-1401-2016 | 05-05-2016 | 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. | Pharmedium Services, LLC / 90 bags | 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-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-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-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-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-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-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-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-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-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 |
