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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1098-2016 | 03-25-2016 | All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1117-2016 | 03-25-2016 | All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1088-2016 | 03-25-2016 | All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1069-2016 | 03-25-2016 | All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1085-2016 | 03-25-2016 | All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1081-2016 | 03-25-2016 | All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1120-2016 | 03-25-2016 | All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1072-2016 | 03-25-2016 | All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1075-2016 | 03-25-2016 | All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1106-2016 | 03-25-2016 | All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1131-2016 | 03-25-2016 | All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1124-2016 | 03-25-2016 | All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1130-2016 | 03-25-2016 | All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1095-2016 | 03-25-2016 | All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1078-2016 | 03-25-2016 | All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1125-2016 | 03-25-2016 | All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1113-2016 | 03-25-2016 | All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1068-2016 | 03-25-2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Reliable Rexall-A Compounding Pharmacy / N/A | Class I | Terminated |
| D-1097-2016 | 03-25-2016 | All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1134-2016 | 03-25-2016 | All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1123-2016 | 03-25-2016 | All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1136-2016 | 03-25-2016 | All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1092-2016 | 03-25-2016 | All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1102-2016 | 03-25-2016 | All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1100-2016 | 03-25-2016 | All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1086-2016 | 03-25-2016 | All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1090-2016 | 03-25-2016 | All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1115-2016 | 03-25-2016 | All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1093-2016 | 03-25-2016 | All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1096-2016 | 03-25-2016 | All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1099-2016 | 03-25-2016 | All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1083-2016 | 03-25-2016 | All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1112-2016 | 03-25-2016 | All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1109-2016 | 03-25-2016 | All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1101-2016 | 03-25-2016 | All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1103-2016 | 03-25-2016 | All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1121-2016 | 03-25-2016 | All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-0837-2016 | 03-25-2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch. Package NDCs: 63629-3324-1; 63629-3324-2; 63629-3324-3; 63629-3324-4; 63629-3324-5; 63629-3324-6; 36290-3324-2 | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation. | Bryant Ranch Prepack Inc. / 21 bottles (910 extended release tablets) | Class III | Terminated |
| D-1094-2016 | 03-25-2016 | All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1070-2016 | 03-25-2016 | All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1114-2016 | 03-25-2016 | All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1126-2016 | 03-25-2016 | All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1076-2016 | 03-25-2016 | All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1111-2016 | 03-25-2016 | All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1082-2016 | 03-25-2016 | All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-0094-2017 | 03-25-2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32 | Non-Sterility: fungal contamination due to leaking containers. | B. Braun Medical Inc / 57,408 units | Class I | Terminated |
| D-1516-201 | 03-24-2016 | Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01 Package NDCs: 68180-137-01; 68180-137-06; 68180-135-01; 68180-136-01 | Labeling: Incorrect or Missing Lot and/or Expiration Date | Lupin Limited / 3,192 bottles (319,200 tablets) | Class III | Terminated |
| D-0833-2016 | 03-24-2016 | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30. Package NDCs: 0074-4314-30; 0074-4317-30; 0074-4317-73; 0074-9036-30; 0074-9037-30 | Failed Content Uniformity Specifications | AbbVie Inc. / 307 bottles | Class III | Terminated |
| D-0817-2016 | 03-24-2016 | Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134 | Subpotent Drug | Biocon Inc / 5505 bottles | Class III | Terminated |
| D-1137-2016 | 03-23-2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5. | Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. | Hospira Inc. / 88,500 vials | Class I | Ongoing |
| D-0854-2016 | 03-23-2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5. | Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. | Hospira Inc. / 715,200 vials | Class III | Ongoing |
| D-0874-2016 | 03-23-2016 | ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. | Akorn, Inc. / 33,862 mL | Class II | Terminated |
| D-0876-2016 | 03-23-2016 | PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701 | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. | Akorn, Inc. / 294,090 mL | Class II | Terminated |
| D-0855-2016 | 03-23-2016 | Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03 | Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent. | TMIG Inc / unknown | Class II | Terminated |
| D-0875-2016 | 03-23-2016 | Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16 | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. | Akorn, Inc. / 3,112,657 mL | Class II | Terminated |
| D-0865-2016 | 03-18-2016 | 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02 | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Hospira Inc. / 72,000 units | Class I | Ongoing |
| D-0821-2016 | 03-17-2016 | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Impax Laboratories, Inc. / 42,239 HDPE bottles ( 21,119,500 capsules) | Class III | Terminated |
| D-0820-2016 | 03-17-2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Impax Laboratories, Inc. / 28,001 HDPE bottles (14,000,500 capsules) | Class III | Terminated |
| D-1060-2016 | 03-16-2016 | Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10 | Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month). | Actavis Pharma Inc / 447,150 Bottles | Class III | Terminated |
| D-0836-2016 | 03-15-2016 | Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02 Package NDCs: 0409-6629-12; 0409-6629-02; 0409-6970-10 | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial. | Hospira Inc. / 103,600 vials | Class III | Ongoing |
| D-0808-2016 | 03-14-2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0803-2016 | 03-14-2016 | Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. . | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0807-2016 | 03-14-2016 | Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0826-2016 | 03-14-2016 | Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10 | Failed Impurities/Degradation Specifications | Impax Laboratories, Inc. / 18,936 bottles | Class II | Terminated |
| D-0802-2016 | 03-14-2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Superpotent Drug: one ingredient was found to be above assay specification. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0804-2016 | 03-14-2016 | Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0805-2016 | 03-14-2016 | Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0825-2016 | 03-14-2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 | Failed Impurities/Degradation Specifications | Impax Laboratories, Inc. / 67,428 bottles | Class II | Terminated |
| D-0806-2016 | 03-14-2016 | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. | Meditech Laboratories, Inc / 1320 vials - all formulas | Class II | Terminated |
| D-0953-2016 | 03-11-2016 | Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 30586 vials | Class III | Terminated |
| D-0812-2016 | 03-11-2016 | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 Package NDCs: 65174-461-05 | Labeling: Label Error on Declared Strength | Jubilant Draximage Inc / 90 vials (450 capsules) | Class III | Terminated |
| D-0954-2016 | 03-11-2016 | Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 570 vials | Class III | Terminated |
| D-0955-2016 | 03-11-2016 | Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India. | CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 741.171 kg | Class III | Terminated |
| D-0951-2016 | 03-11-2016 | Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 15408 vials | Class III | Terminated |
| D-0952-2016 | 03-11-2016 | Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 7908 vials | Class III | Terminated |
| D-0859-2016 | 03-09-2016 | Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03 | Presence of Particulate Matter: particulate matter identified as glass in one vial. | Teva Pharmaceuticals USA / 6,291 units | Class I | Terminated |
| D-0829-2016 | 03-08-2016 | Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 552 bags | Class II | Terminated |
| D-0830-2016 | 03-08-2016 | Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 1776 bags | Class II | Terminated |
| D-0827-2016 | 03-08-2016 | Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 11256 bags | Class II | Terminated |
| D-0828-2016 | 03-08-2016 | Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 4368 bags | Class II | Terminated |
| D-0832-2016 | 03-08-2016 | Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 81888 bags | Class II | Terminated |
| D-0831-2016 | 03-08-2016 | Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2 | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. / 22292 bags | Class II | Terminated |
| D-0784-2016 | 03-03-2016 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52 Package NDCs: 55111-688-52 | Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial | Dr. Reddy's Laboratories, Inc. / 3,342 vials | Class II | Terminated |
| D-0780-2016 | 03-01-2016 | Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82 | Cross contamination with other products: metronidazole | Sagent Pharmaceuticals Inc / 37,450 bags | Class II | Terminated |
| D-0856-2016 | 02-29-2016 | col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011. | Superpotent Drug: High out of specification results for assay at the 6 month time point interval. | Allegiant Health / a) 9816 bottles; b) 9648 bottles | Class III | Terminated |
| D-0824-2016 | 02-25-2016 | Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4. | Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet. | Torrent Pharmaceuticals Limited / 20,952 cartons | Class III | Terminated |
| D-1493-2016 | 02-19-2016 | Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03 Package NDCs: 68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-03; 68180-719-09; 68180-720-09; 68180-720-03; 68180-721-03; 68180-721-09; 68180-233-01; 68180-233-02; 68180-455-02; 68180-455-01 | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Limited / 11,812 bottles | Class III | Terminated |
| D-1492-2016 | 02-19-2016 | Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09 Package NDCs: 68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-03; 68180-719-09; 68180-720-09; 68180-720-03; 68180-721-03; 68180-721-09; 68180-233-01; 68180-233-02; 68180-455-02; 68180-455-01 | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Limited / 43,536 bottles | Class III | Terminated |
| D-0816-2016 | 02-16-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Actavis Elizabeth LLC / 38,507 Bottles | Class II | Terminated |
| D-0813-2016 | 02-16-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Actavis Elizabeth LLC / 114,388 Bottles | Class II | Terminated |
| D-0814-2016 | 02-16-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Actavis Elizabeth LLC / 257,746 Bottles | Class II | Terminated |
| D-0815-2016 | 02-16-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Actavis Elizabeth LLC / 182,378 Bottles | Class II | Terminated |
| D-0729-2016 | 02-16-2016 | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04. | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Genzyme Corporation / 27,022 vials | Class II | Terminated |
| D-0730-2016 | 02-16-2016 | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2. Package NDCs: 58468-0030-1; 58468-0030-2; 58468-1849-4 | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Genzyme Corporation / 4669 Cartons | Class II | Terminated |
| D-0766-2016 | 02-12-2016 | Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102 Package NDCs: 47593-468-41; 47593-468-59; 47593-468-44; 47593-468-21; 47593-468-36; 47593-265-36 | Subpotent drug | Ecolab Inc / 706 bottles | Class III | Terminated |
| D-0796-2016 | 02-12-2016 | Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61 | Lack of Assurance of Sterility | Walter's Pharmacy / 5 bottles | Class II | Terminated |
| D-0789-2016 | 02-12-2016 | Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706 | Lack of Assurance of Sterility | Walter's Pharmacy / 3 bottles | Class II | Terminated |
| D-0790-2016 | 02-12-2016 | Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92 | Lack of Assurance of Sterility | Walter's Pharmacy / 1 bottle | Class II | Terminated |
| D-0787-2016 | 02-12-2016 | Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47 | Lack of Assurance of Sterility | Walter's Pharmacy / 3 bottles | Class II | Terminated |
| D-0788-2016 | 02-12-2016 | Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99 | Lack of Assurance of Sterility | Walter's Pharmacy / 5 bottles | Class II | Terminated |
