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-0604-2024 | 05-30-2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01 Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05 | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA / 285,840 bottles | Class I | Ongoing |
| D-0559-2024 | 05-30-2024 | Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03 Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08 | Failed Content Uniformity Specifications | Lupin Pharmaceuticals Inc. / 3,552 bottles | Class II | Terminated |
| D-0605-2024 | 05-30-2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05 Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05 | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA / 36,630 bottles | Class I | Ongoing |
| D-0607-2024 | 05-30-2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05 Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0606-2024 | 05-30-2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01 Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0553-2024 | 05-28-2024 | Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 Package NDCs: 25021-254-08; 25021-254-16 | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Sagent Pharmaceuticals / 762 vials | Class I | Ongoing |
| D-0552-2024 | 05-28-2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04 | Defective Container | Organon Llc / 0 | Class III | Ongoing |
| D-0554-2024 | 05-28-2024 | Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 Package NDCs: 25021-254-08; 25021-254-16 | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Sagent Pharmaceuticals / 2806 vials | Class I | Ongoing |
| D-0557-2024 | 05-28-2024 | Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02 Package NDCs: 63029-103-01; 63029-103-02 | cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. | Denison Pharmaceuticals, LLC / 113,544 bottles | Class II | Terminated |
| D-0551-2024 | 05-28-2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03 Package NDCs: 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01 | Defective Container | Organon Llc / 2,551 units | Class III | Ongoing |
| D-0550-2024 | 05-28-2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02 Package NDCs: 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01 | Defective Container | Organon Llc / 2,886 units | Class III | Ongoing |
| D-0560-2024 | 05-28-2024 | Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0 Package NDCs: 11822-3135-4; 11822-3135-2; 30142-069-07; 30142-069-27; 30142-069-54; 72036-069-27; 72036-069-54; 59779-069-27; 59779-069-54; 59779-069-18; 59779-069-96 | Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile | Consumer Product Partners, LLC / 1015 cases | Class II | Terminated |
| D-0545-2024 | 05-28-2024 | Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10, Package NDCs: 75826-114-10; 75826-115-10 | Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. | Winder Laboratories, LLC / 473 cases (5676 Bottles) | Class II | Completed |
| D-0589-2024 | 05-24-2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA Package NDCs: 69949-151-01; 69949-152-01; 69949-153-01; 69949-154-01; 69949-155-01; 69949-156-01; 69949-157-01; 8542450061; 8542450062; 8542450064 | CGMP Deviations | SYNCHRONICITY SPA INC, DBA SUNTE / 8202 tubes | Class II | Ongoing |
| D-0588-2024 | 05-24-2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187 Package NDCs: 69949-151-01; 69949-152-01; 69949-153-01; 69949-154-01; 69949-155-01; 69949-156-01; 69949-157-01; 8542450061 | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) | SYNCHRONICITY SPA INC, DBA SUNTE / 1,902 tubes | Class I | Ongoing |
| D-0510-2024 | 05-23-2024 | Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52 Package NDCs: 55111-688-52 | Lack of Assurance of Sterility: Leaking vials | Dr. Reddy's Laboratories, Inc. / 13,880 vials | Class II | Ongoing |
| D-0555-2024 | 05-23-2024 | Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30 Package NDCs: 55150-237-01; 55150-238-05; 55150-239-30 | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. | Eugia US LLC / 70,125 vials | Class II | Ongoing |
| D-0558-2024 | 05-22-2024 | OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol, | MexHealth LLC / 20 bottles | Class II | Ongoing |
| D-0556-2024 | 05-22-2024 | Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10 Package NDCs: 55150-218-99; 55150-219-10; 55150-220-99 | Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. | Eugia US LLC / 15,500 single dose vials | Class III | Ongoing |
| D-0566-2024 | 05-20-2024 | Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606 Package NDCs: 0904-6730-60; 0904-6730-80; 0904-6730-59; 0904-6730-61; 3090467306 | Discoloration: Brownish tablets | Contract Pharmacal Corporation / 14,616 bottles | Class II | Ongoing |
| D-0565-2024 | 05-20-2024 | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24 Package NDCs: 0409-2339-24; 0409-2339-34 | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. / 220,400 cartridges | Class II | Ongoing |
| D-0564-2024 | 05-20-2024 | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03 Package NDCs: 0409-2012-03; 0409-2012-32 | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. / 84,710 cartridges | Class II | Ongoing |
| D-0509-2024 | 05-20-2024 | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 Package NDCs: 50242-041-64; 50242-041-10 | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. | Genentech, Inc. / Lot:3618858 = 105,759; Lot:3618873 =90,359 | Class II | Terminated |
| D-0562-2024 | 05-17-2024 | Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc / 165,678, 90-count bottles | Class II | Terminated |
| D-0544-2024 | 05-17-2024 | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37 Package NDCs: 49702-255-37; 49702-226-13; 49702-227-13; 49702-228-13 | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR. | GlaxoSmithKline LLC / 463 Cartons | Class III | Terminated |
| D-0541-2024 | 05-16-2024 | Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10 Package NDCs: 64980-410-09; 64980-410-10; 64980-410-01; 64980-411-09; 64980-411-10; 64980-411-01; 64980-412-09; 64980-412-10; 64980-412-01; 64980-413-09; 64980-413-10; 64980-413-01; 64980-414-09; 64980-414-10; 64980-414-01; 64980-415-09; 64980-415-10; 64980-415-01; 64980-416-09; 64980-416-10; 64980-416-01; 64980-417-09; 64980-417-10; 64980-417-01 | Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg. | Rising Pharma Holding, Inc. / N/A | Class III | Ongoing |
| D-0543-2024 | 05-16-2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8 Package NDCs: 70710-1191-1; 70710-1191-8; 70710-1192-1; 70710-1192-8; 70710-1193-1; 70710-1193-8; 70710-1194-1; 70710-1194-8; 70710-1195-1; 70710-1195-8 | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc / 13,440 units | Class III | Ongoing |
| D-0542-2024 | 05-16-2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8 Package NDCs: 70710-1191-1; 70710-1191-8; 70710-1192-1; 70710-1192-8; 70710-1193-1; 70710-1193-8; 70710-1194-1; 70710-1194-8; 70710-1195-1; 70710-1195-8 | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc / 21,360 units | Class III | Ongoing |
| D-0531-2024 | 05-15-2024 | EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54 Package NDCs: 61755-005-02; 61755-005-55; 61755-005-01; 61755-005-54; 8231500321; 8231500335; 8231500333; 8231500334; 8231500339; 8231500347; 8231500336; 8231500337; 8231500340; 8268700014 | Lack of Assurance of Sterility: Complaints of syringe breakage | Regeneron Pharmaceuticals Inc / 405,725 Prefilled syringes | Class II | Terminated |
| D-0514-2024 | 05-14-2024 | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 38,060 vials | Class II | Ongoing |
| D-0512-2024 | 05-14-2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 14,180 vials | Class II | Ongoing |
| D-0516-2024 | 05-14-2024 | Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 165,920 vials | Class II | Ongoing |
| D-0547-2024 | 05-14-2024 | Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 136,005 units | Class II | Ongoing |
| D-0548-2024 | 05-14-2024 | Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 4,280 boxes | Class II | Ongoing |
| D-0513-2024 | 05-14-2024 | Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 39,700 vials | Class II | Ongoing |
| D-0519-2024 | 05-14-2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 74,440 units | Class II | Ongoing |
| D-0515-2024 | 05-14-2024 | Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08 | Lack of Assurance of Sterility | Imprimis NJOF, LLC / 18,980 vials | Class II | Ongoing |
| D-0503-2024 | 05-14-2024 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10 Package NDCs: 72572-470-01; 72572-470-10 | Lack of Assurance of Sterility. | American Regent, Inc. / 4,136 cartons (10 vials in each carton) | Class II | Terminated |
| D-0507-2024 | 05-13-2024 | Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01 Package NDCs: 0517-1020-01; 0517-1020-25; 0517-1030-01 | Subpotent product in addition to having out-of-specification results for impurities. | American Regent, Inc. / 2,352 vials | Class II | Terminated |
| D-0535-2024 | 05-13-2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06 Package NDCs: 68462-467-74; 68462-467-46; 68462-467-06; 68462-468-74; 68462-468-46; 68462-468-06 | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA / 13296 cartons | Class II | Ongoing |
| D-0568-2024 | 05-13-2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-164-60; 60429-165-30; 60429-165-90; 60429-166-30; 60429-166-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. | Golden State Medical Supply Inc. / 21,655 (30 count bottle), 34,149 (90 count bottle) | Class II | Terminated |
| D-0534-2024 | 05-13-2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06 Package NDCs: 68462-467-74; 68462-467-46; 68462-467-06; 68462-468-74; 68462-468-46; 68462-468-06 | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA / 2400 cartons | Class II | Ongoing |
| D-0538-2024 | 05-10-2024 | Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1. Package NDCs: 63629-8858-1 | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' | Bryant Ranch Prepack, Inc. / 104 bottles | Class III | Ongoing |
| D-0532-2024 | 05-10-2024 | Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99 Package NDCs: 68462-465-72; 68462-465-99; 68462-466-72; 68462-466-99 | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA / 3,480 cartons | Class II | Ongoing |
| D-0533-2024 | 05-10-2024 | Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99 Package NDCs: 68462-465-72; 68462-465-99; 68462-466-72; 68462-466-99 | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA / 11,976 cartons | Class II | Ongoing |
| D-0540-2024 | 05-10-2024 | Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1. Package NDCs: 63629-9207-1 | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' | Bryant Ranch Prepack, Inc. / 61 Bottles | Class III | Ongoing |
| D-0537-2024 | 05-10-2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1. Package NDCs: 63629-9205-1 | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g | Bryant Ranch Prepack, Inc. / 6 bottles | Class III | Ongoing |
| D-0536-2024 | 05-10-2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1. Package NDCs: 63629-9204-1 | Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g' | Bryant Ranch Prepack, Inc. / 156 bottles | Class III | Ongoing |
| D-0539-2024 | 05-10-2024 | Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1. Package NDCs: 63629-9206-1 | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' | Bryant Ranch Prepack, Inc. / 190 bottles | Class III | Ongoing |
| D-0505-2024 | 05-10-2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Preferred Pharmaceuticals, Inc. / 66 bottles of 30 tablets | Class II | Ongoing |
| D-0518-2024 | 05-08-2024 | Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Defective container: lack of seal integrity. | Lupin Pharmaceuticals Inc. / 51,006 bottles | Class II | Terminated |
| D-0546-2024 | 05-07-2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01. Package NDCs: 65250-003-01; 65250-001-01; 65250-002-01 | Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. | PACIRA PHARMACEUTICALS INC / 43,768 kits | Class II | Ongoing |
| D-0498-2024 | 05-07-2024 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | Presence of foreign substance: plastic-like substance. | MACLEODS PHARMA USA, INC / 1,048 bottles | Class II | Ongoing |
| D-0517-2024 | 05-06-2024 | Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00 Package NDCs: 52817-362-10; 52817-362-00; 52817-359-10; 52817-359-50; 52817-361-10; 52817-361-00; 52817-360-10; 52817-360-00; 52817-358-10; 52817-358-50 | Presence of Foreign Substance: metal in tablet | Rubicon Research Private Limited / 11,664 Bottles | Class II | Ongoing |
| D-0489-2024 | 05-02-2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762 | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol | RemedyRepack Inc. / 23,970 Tablets | Class II | Terminated |
| D-0500-2024 | 05-01-2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10. Package NDCs: 51316-881-10 | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC / 120830 | Class II | Ongoing |
| D-0501-2024 | 05-01-2024 | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9 Package NDCs: 79481-0034-9 | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC / 24840 | Class II | Ongoing |
| D-0504-2024 | 05-01-2024 | Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 Package NDCs: 55111-653-30; 55111-653-01; 55111-654-30; 55111-654-01 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 1,176 bottles | Class III | Ongoing |
| D-0603-2024 | 04-30-2024 | Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10 | Failed Impurities/Degradation Specifications | Viatris Inc / 3,694 bottles | Class II | Completed |
| D-0602-2024 | 04-30-2024 | Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10 | Failed Impurities/Degradation Specifications | Viatris Inc / 12,691 bottles | Class II | Completed |
| D-0480-2024 | 04-30-2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05 | Labeling: Wrong Barcode | Hikma Injectables USA Inc / 1,895 bags | Class III | Completed |
| D-0482-2024 | 04-29-2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc / 281,554/90 & 1000 count bottles | Class II | Ongoing |
| D-0483-2024 | 04-29-2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc / 7,188/ 500 count bottles | Class II | Ongoing |
| D-0484-2024 | 04-29-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc / 281,554/90 count bottles | Class II | Ongoing |
| D-0508-2024 | 04-29-2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25 | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. | Hikma Injectables USA Inc / | Class I | Completed |
| D-0487-2024 | 04-26-2024 | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00 Package NDCs: 72888-162-30; 72888-162-01; 72888-162-05; 72888-162-00; 72888-080-01; 72888-080-05; 72888-080-00; 72888-163-30; 72888-163-01; 72888-163-05; 72888-163-00; 72888-008-01; 72888-008-05; 72888-008-00 | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol | Rubicon Research Private Limited / 2,592 1000-count Bottles | Class II | Ongoing |
| D-0481-2024 | 04-25-2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 Package NDCs: 0378-4275-93; 0378-4275-77; 0378-4276-93; 0378-4276-77 | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets. | Viatris Inc / 143,230 bottles | Class III | Completed |
| D-0499-2024 | 04-25-2024 | MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10 Package NDCs: 25021-820-05; 25021-820-10; 25021-821-05 | Presence of Particulate Matter: Potential for black particulates in the drug product. | Sagent Pharmaceuticals / 14,360 vials | Class II | Ongoing |
| D-0488-2024 | 04-25-2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. | FDC Limited / 382,104 units | Class II | Terminated |
| D-0563-2024 | 04-24-2024 | Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024. | Presence of Foreign Substance; Broken metal piece found embedded in tablet. | Coast Quality Pharmacy, LLC dba Anazao Health / 9896 tablets | Class II | Completed |
| D-0490-2024 | 04-24-2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 Package NDCs: 42192-136-06; 42192-136-08; 42192-136-12 | Subpotent drug | Acella Pharmaceuticals, LLC / 7104 Bottles | Class III | Terminated |
| D-0496-2024 | 04-24-2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. / 17,070 bottles | Class II | Terminated |
| D-0497-2024 | 04-24-2024 | Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. / 17,040 bottles | Class II | Terminated |
| D-0492-2024 | 04-24-2024 | Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Package NDCs: 13107-282-01; 13107-282-05; 13107-283-01; 13107-283-05; 13107-284-01 | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. / 6909 bottles | Class II | Ongoing |
| D-0506-2024 | 04-24-2024 | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India. Package NDCs: 70069-030-05; 70069-030-03; 70069-031-01; 70069-031-05; 70069-381-01; 70069-381-10; 70069-382-01; 70069-382-05; 70069-383-05; 70069-383-10; 70069-383-01; 70069-384-01; 70069-384-05 | Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). | SOMERSET THERAPEUTICS LLC / 5,578 units | Class II | Ongoing |
| D-0491-2024 | 04-24-2024 | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Package NDCs: 13107-282-01; 13107-282-05; 13107-283-01; 13107-283-05; 13107-284-01 | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. / 6696 bottles | Class II | Ongoing |
| D-0474-2024 | 04-23-2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30. | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 12808 bottles | Class II | Terminated |
| D-0473-2024 | 04-23-2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90 | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 18645 tubes | Class II | Terminated |
| D-0475-2024 | 04-23-2024 | minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30. | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 5664 bottles | Class II | Terminated |
| D-0479-2024 | 04-23-2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01 Package NDCs: 61755-005-02; 61755-005-55; 61755-005-01; 61755-005-54; 8231500321; 8231500335; 8231500333; 8231500334; 8231500339; 8231500347 | Lack of Assurance of Sterility: Complaints of syringe breakage | Regeneron Pharmaceuticals Inc / 251,504 syringes | Class II | Terminated |
| D-0502-2024 | 04-22-2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90 Package NDCs: 47335-317-90; 47335-317-98; 47335-317-92; 47335-317-94 | Failed Release Testing: Out of specification for particulate matter test. | SUN PHARMACEUTICAL INDUSTRIES INC / 35,069 bottles | Class III | Ongoing |
| D-0494-2024 | 04-22-2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV. | Marketed Without An Approved NDA/ANDA | Stop Clopez Corp / 5 boxes | Class I | Terminated |
| D-0511-2024 | 04-20-2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64 | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Revive Rx LLC dba Revive Rx Pharmacy / 751 vials | Class I | Ongoing |
| D-0493-2024 | 04-19-2024 | Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01 Package NDCs: 62756-233-01; 62756-233-02 | Out of specification for assay | SUN PHARMACEUTICAL INDUSTRIES INC / 11,016 vials | Class II | Ongoing |
| D-0462-2024 | 04-19-2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. Package NDCs: 51801-003-50; 51801-003-40 | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 15,056 cartons | Class II | Ongoing |
| D-0465-2024 | 04-19-2024 | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01. | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 15,444 cartons | Class II | Ongoing |
| D-0463-2024 | 04-19-2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40. Package NDCs: 51801-009-50; 51801-009-40 | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 6,960 cartons | Class II | Ongoing |
| D-0464-2024 | 04-19-2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03. | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 4648 cartons | Class II | Ongoing |
| D-0472-2024 | 04-17-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA / 3,264 bottles | Class II | Ongoing |
| D-0529-2024 | 04-17-2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 1,680 | Class II | Ongoing |
| D-0520-2024 | 04-17-2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 3,440 | Class II | Ongoing |
| D-0521-2024 | 04-17-2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 192 | Class II | Ongoing |
| D-0523-2024 | 04-17-2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands. | Out of Specification for active ingredient | ARG Laboratories, Inc. / 4,013 | Class II | Ongoing |
| D-0524-2024 | 04-17-2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 7,410 | Class II | Ongoing |
| D-0522-2024 | 04-17-2024 | Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5 | Out of Specification for active ingredient | ARG Laboratories, Inc. / 9,697 | Class II | Ongoing |
| D-0526-2024 | 04-17-2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 500 | Class II | Ongoing |
| D-0528-2024 | 04-17-2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 3,504 | Class II | Ongoing |
| D-0525-2024 | 04-17-2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 2,864 | Class II | Ongoing |
| D-0527-2024 | 04-17-2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4 | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. / 3,000 | Class II | Ongoing |
| D-0530-2024 | 04-17-2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7 | Out of Specification for active ingredient | ARG Laboratories, Inc. / 6,264 | Class II | Ongoing |
