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-1179-2015 | 05-28-2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 12 Bags | Class II | Terminated |
| D-1171-2015 | 05-28-2015 | VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1155-2015 | 05-28-2015 | TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 4 Bags | Class II | Terminated |
| D-1198-2015 | 05-28-2015 | Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1182-2015 | 05-28-2015 | VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1162-2015 | 05-28-2015 | TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 5 Bags | Class II | Terminated |
| D-1154-2015 | 05-28-2015 | TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1197-2015 | 05-28-2015 | Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1183-2015 | 05-28-2015 | DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1166-2015 | 05-28-2015 | Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 4 Bags | Class II | Terminated |
| D-1201-2015 | 05-28-2015 | Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 15 Bags | Class II | Terminated |
| D-1203-2015 | 05-28-2015 | Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1181-2015 | 05-28-2015 | VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1156-2015 | 05-28-2015 | TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1176-2015 | 05-28-2015 | FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1200-2015 | 05-28-2015 | Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1159-2015 | 05-28-2015 | TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1195-2015 | 05-28-2015 | GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Syringes | Class II | Terminated |
| D-1185-2015 | 05-28-2015 | CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1180-2015 | 05-28-2015 | Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1184-2015 | 05-28-2015 | CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1168-2015 | 05-28-2015 | Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1202-2015 | 05-28-2015 | HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1170-2015 | 05-28-2015 | Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1147-2015 | 05-27-2015 | E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01 | Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. | Bracco Diagnostic Inc / 1008 boxes | Class III | Terminated |
| D-1138-2015 | 05-22-2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland. | Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. | Novartis Pharmaceuticals Corp. / 55,442 packs | Class III | Terminated |
| D-1110-2015 | 05-22-2015 | Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02 | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure | Blenheim Pharmacal, Inc. / 50 bottles | Class II | Terminated |
| D-1137-2015 | 05-22-2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland. | Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. | Novartis Pharmaceuticals Corp. / 19,658 packs | Class III | Terminated |
| D-1109-2015 | 05-22-2015 | Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02 | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure | Blenheim Pharmacal, Inc. / 166 bottles | Class II | Terminated |
| D-0658-2016 | 05-22-2015 | Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44. | Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. | Pharmedium Services, LLC / 19 Syringes | Class I | Terminated |
| D-1135-2015 | 05-22-2015 | Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India Package NDCs: 55111-533-30; 55111-533-60; 55111-533-01; 55111-533-05; 55111-533-79; 55111-533-78 | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Dr. Reddy's Laboratories, Inc. / 100 count 7479; 500 count - 2544 | Class II | Terminated |
| D-1136-2015 | 05-22-2015 | Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01 Package NDCs: 55111-534-30; 55111-534-60; 55111-534-01; 55111-534-05 | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Dr. Reddy's Laboratories, Inc. / 5,160 bottles | Class II | Terminated |
| D-1113-2015 | 05-21-2015 | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433 | Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin. | Medtech Products, Inc. / 107,832 tins | Class II | Terminated |
| D-1206-2015 | 05-21-2015 | CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99. | Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. | Takeda Pharmaceuticals North America, Inc. / 3,619 bottles | Class II | Terminated |
| D-1111-2015 | 05-20-2015 | Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7. | Failed Dissolution Specifications: Low out of specification dissolution results. | Mylan Lab Inc / 7,722 bottles | Class II | Terminated |
| D-1232-2015 | 05-19-2015 | Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02 | Failed pH Specifications: 12 month stability testing | Hospira Inc. / 106,900 vials | Class III | Terminated |
| D-1099-2015 | 05-18-2015 | HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 3 vials | Class II | Terminated |
| D-1106-2015 | 05-18-2015 | SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1102-2015 | 05-18-2015 | NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 30 vials | Class II | Terminated |
| D-1096-2015 | 05-18-2015 | GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / | Class II | Terminated |
| D1091-2015 | 05-18-2015 | DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 41 vials | Class II | Terminated |
| D-1094-2015 | 05-18-2015 | ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 17 vials | Class II | Terminated |
| D1092-2015 | 05-18-2015 | ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 6 vials | Class II | Terminated |
| D-1098-2015 | 05-18-2015 | HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 28 vials | Class II | Terminated |
| D-1101-2015 | 05-18-2015 | NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 32 vials | Class II | Terminated |
| D-1093-2015 | 05-18-2015 | ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 21 vials | Class II | Terminated |
| D-1107-2015 | 05-18-2015 | VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 2 vials | Class II | Terminated |
| D-1095-2015 | 05-18-2015 | ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1105-2015 | 05-18-2015 | SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1097-2015 | 05-18-2015 | GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1090-2015 | 05-18-2015 | CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 77 vials | Class II | Terminated |
| D-1103-2015 | 05-18-2015 | SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 416 syringes | Class II | Terminated |
| D-1104-2015 | 05-18-2015 | SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 21 vials | Class II | Terminated |
| D-1100-2015 | 05-18-2015 | HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 2 vials | Class II | Terminated |
| D-1121-2015 | 05-15-2015 | Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 20/4 mL vials | Class II | Terminated |
| D-1123-2015 | 05-15-2015 | Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 20/1 mL vials | Class II | Terminated |
| D-1122-2015 | 05-15-2015 | Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 10/3 mL vials | Class II | Terminated |
| D-1132-2015 | 05-15-2015 | MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04 Package NDCs: 0019-4816-04 | Labeling: incorrect or missing lot number and/or expiration date | Mallinckrodt, Inc. / 6600 bottles | Class II | Terminated |
| D-1117-2015 | 05-15-2015 | Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5mL vial | Class II | Terminated |
| D-1126-2015 | 05-15-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 25/5 mL. vials | Class II | Terminated |
| D-1119-2015 | 05-15-2015 | Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 259/0.05 mL Syringes | Class II | Terminated |
| D-1124-2015 | 05-15-2015 | Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/1 mL. vial | Class II | Terminated |
| D-1127-2015 | 05-15-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 2/5 mL vials | Class II | Terminated |
| D-1118-2015 | 05-15-2015 | Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5 mL vial | Class II | Terminated |
| D-1125-2015 | 05-15-2015 | Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 32/2 mL vials | Class II | Terminated |
| D-1128-2015 | 05-15-2015 | Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5 mL vial | Class II | Terminated |
| D-1120-2015 | 05-15-2015 | Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5mL vial | Class II | Terminated |
| D-1139-2015 | 05-13-2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25. Package NDCs: 0641-6024-01; 0641-6024-10; 0641-6027-01; 0641-6027-25; 0641-6025-01; 0641-6025-10; 0641-6028-01; 0641-6028-10; 0641-6028-25; 0641-6026-01; 0641-6026-05; 0641-6029-01; 0641-6029-25; 0641-6030-01; 0641-6247-01; 0641-6247-25; 0641-6248-01; 0641-6248-10; 0641-6249-01; 0641-6249-10 | Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). | West-Ward Pharmaceutical Corp. / 14,649 Cartons | Class III | Terminated |
| D-1134-2015 | 05-12-2015 | Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2. | CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. | Allegiant Health / 86,106 Cartons | Class II | Terminated |
| D-1112-2015 | 05-11-2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01 | Failed Dissolution Specifications: OOS result during stability testing | Teva Pharmaceuticals USA / 889 bottles | Class II | Terminated |
| D-1087-2015 | 05-07-2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12 | Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing. | Teva Pharmaceuticals USA / 233,364 Inhalers | Class III | Terminated |
| D-1145-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90 Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1144-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1146-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1143-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1142-2015 | 05-04-2015 | Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand) | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 2592 Blister Packs | Class III | Terminated |
| D-1064-2015 | 04-30-2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23 | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Mission Pharmacal Co / 2,412 Kits | Class II | Terminated |
| D-1065-2015 | 04-30-2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23 | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Mission Pharmacal Co / 1,992 Kits | Class II | Terminated |
| D-1063-2015 | 04-29-2015 | Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15. | Subpotent Drug | Janssen Pharmaceuticals, Inc. / 16,861 cartons/6 blister units (28 tablets) each | Class II | Terminated |
| D-0561-2016 | 04-29-2015 | Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07. | cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. | PD-Rx Pharmaceuticals, Inc. / 17,533 bottles | Class II | Terminated |
| D-0560-2016 | 04-29-2015 | Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04. | cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. | PD-Rx Pharmaceuticals, Inc. / 45,022 bottles | Class II | Terminated |
| D-1089-2015 | 04-28-2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11 | Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. | Teva Pharmaceuticals USA / 6195 vials | Class I | Terminated |
| D-1133-2015 | 04-28-2015 | PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029. | Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose. | SCA Pharmaceuticals / 50 bags | Class II | Terminated |
| D-1114-2015 | 04-28-2015 | KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20. Package NDCs: 63323-712-10; 63323-712-15; 63323-712-20; 63323-712-25 | Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids | Fresenius Kabi USA, LLC / 5,488 Bags | Class II | Terminated |
| D-1078-2015 | 04-24-2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25. | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Cipla Limited / 140,625 Vials | Class III | Terminated |
| D-0983-2015 | 04-24-2015 | Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607 | Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity | Romark Laboratories, L.C. / 32,893 bottles | Class II | Terminated |
| D-1337-2015 | 04-23-2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / ALL LOTS | Class II | Terminated |
| D-1329-2015 | 04-23-2015 | Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017. | Presence of Particulate Matter | Mylan Institutional LLC / 8,340 vials | Class I | Terminated |
| D-1412-2015 | 04-23-2015 | Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 211 presciptions | Class II | Terminated |
| D-1414-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 36 prescriptions | Class II | Terminated |
| D-1339-2015 | 04-23-2015 | Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 40 capsules ( 1 prescription) | Class II | Terminated |
| D-1410-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 5 prescriptions | Class II | Terminated |
| D-1411-2015 | 04-23-2015 | Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 61 prescriptions | Class II | Terminated |
| D-1338-2015 | 04-23-2015 | Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,355 capsules ( 26 presciptions) | Class II | Terminated |
| D-1407-2015 | 04-23-2015 | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,380 capsules ( 39 prescriptions) | Class II | Terminated |
| D-1415-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 24 suppositories (24 prescriptions) | Class II | Terminated |
| D-1340-2015 | 04-23-2015 | Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 172 vials ( 100 prescriptions) | Class II | Terminated |
| D-1408-2015 | 04-23-2015 | Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,370 capsules (40 prescriptions) | Class II | Terminated |
| D-0974-2015 | 04-23-2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 | Crystallization | RemedyRepack Inc. / 25 | Class II | Terminated |
| D-1216-2015 | 04-23-2015 | Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02. Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. | Hospira Inc. / 150,950 Vials | Class I | Terminated |
