Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0096-2022 | 10-05-2021 | Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3 Package NDCs: 50090-5510-1; 50090-5510-3 | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets. | A-S Medication Solutions LLC. / 72 bottles | Class III | Terminated |
| D-0082-2022 | 10-05-2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05 | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity | Dr. Reddy's Laboratories, Inc. / a) 30,839 bottles, b) 3,830 bottles | Class II | Terminated |
| D-0081-2022 | 10-05-2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles. Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05 | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity | Dr. Reddy's Laboratories, Inc. / a) 776 bottles, b) 84 bottles | Class II | Terminated |
| D-0084-2022 | 10-05-2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05 | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity | Dr. Reddy's Laboratories, Inc. / a) 11,590 bottles b) 3,585 bottles | Class II | Terminated |
| D-0085-2022 | 10-05-2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05 Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05 | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle | Dr. Reddy's Laboratories, Inc. / 696 bottles | Class II | Terminated |
| D-0083-2022 | 10-05-2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05 | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity | Dr. Reddy's Laboratories, Inc. / a) 3,444 bottles b) 469 bottles c) 142 bottles | Class II | Terminated |
| D-0026-2022 | 10-05-2021 | Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1 Package NDCs: 70000-0232-1; 70000-0232-2; 70000-0232-3 | CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. | Dr. Reddy's Laboratories, Inc. / 8,976 bottles | Class II | Terminated |
| D-0004-2022 | 10-04-2021 | Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11 | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point. | Akorn, Inc. / 10,210 bottles | Class II | Terminated |
| D-0253-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2. | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 2,841,012 cans | Class I | Terminated |
| D-0238-2022 | 10-01-2021 | LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, , | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 3,816,468 cans | Class II | Terminated |
| D-0245-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2. | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 2,841,012 cans | Class II | Terminated |
| D-0243-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3. Package NDCs: 11523-0165-3 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 4,990,860 cans | Class II | Terminated |
| D-0237-2022 | 10-01-2021 | LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 4,546,152 cans | Class II | Terminated |
| D-0247-2022 | 10-01-2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 4,546,152 cans | Class I | Terminated |
| D-0241-2022 | 10-01-2021 | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 1,801,332 cans | Class II | Terminated |
| D-0250-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105 Package NDCs: 11523-4162-1 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 738,432 cans | Class I | Terminated |
| D-0239-2022 | 10-01-2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1. Package NDCs: 11523-0010-1; 11523-0010-2 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 77,076 cans | Class II | Terminated |
| D-0248-2022 | 10-01-2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 3,816,468 cans | Class I | Terminated |
| D-0252-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 592,416 cans | Class I | Terminated |
| D-0244-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 592,416 cans | Class II | Terminated |
| D-0246-2022 | 10-01-2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 2,817,468 cans | Class I | Terminated |
| D-0236-2022 | 10-01-2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 2,817,468 cans | Class II | Terminated |
| D-0249-2022 | 10-01-2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2. Package NDCs: 11523-0010-1; 11523-0010-2 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 579,456 cans | Class I | Terminated |
| D-0251-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3. Package NDCs: 11523-0165-3 | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. / 4,990,860 cans | Class I | Terminated |
| D-0254-2022 | 10-01-2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2 Package NDCs: 11523-0010-1; 11523-0010-2; 0004110059 | cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 579,456 units | Class II | Terminated |
| D-0242-2022 | 10-01-2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981 Package NDCs: 11523-4162-1; 11017-410-00 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 738,432 cans | Class II | Terminated |
| D-0240-2022 | 10-01-2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Package NDCs: 11523-0010-1; 11523-0010-2 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. / 579,456 cans | Class II | Terminated |
| D-0013-2022 | 09-30-2021 | Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1 | Chemical contamination; presence of benzene | Beiersdorf Inc / 142,236 cans | Class I | Terminated |
| D-0015-2022 | 09-30-2021 | Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0 | cGMP Deviations | Beiersdorf Inc / 36,660 cans | Class II | Terminated |
| D-0014-2022 | 09-30-2021 | Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9 | Chemical contamination; presence of benzene | Beiersdorf Inc / 143,376 cans | Class I | Terminated |
| D-0011-2022 | 09-30-2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4 | Chemical contamination; presence of benzene | Beiersdorf Inc / 167,808 cans | Class I | Terminated |
| D-0016-2022 | 09-30-2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4 | cGMP Deviations | Beiersdorf Inc / 70,320 cans | Class II | Terminated |
| D-0017-2022 | 09-30-2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7 | cGMP Deviations | Beiersdorf Inc / 14,748 cans | Class II | Terminated |
| D-0010-2022 | 09-30-2021 | Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0 | Chemical contamination; presence of benzene | Beiersdorf Inc / 38,328 cans | Class I | Terminated |
| D-0012-2022 | 09-30-2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7 | Chemical contamination; presence of benzene | Beiersdorf Inc / 124,668 cans | Class I | Terminated |
| D-0364-2022 | 09-28-2021 | The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4 | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8 | Revive Personal Products Company / 258 bottles | Class II | Ongoing |
| D-0257-2022 | 09-28-2021 | Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 574 Bottles | Class III | Ongoing |
| D-0256-2022 | 09-28-2021 | Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504. | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 119 Bottles | Class III | Ongoing |
| D-0002-2022 | 09-27-2021 | Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801. | Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. | AMIVAS (US), LLC / 292 cartons | Class II | Terminated |
| D-0006-2022 | 09-27-2021 | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07. Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08 | Failed Dissolution Specifications | Strides Pharma Inc. / 1813 bottles | Class II | Terminated |
| D-0009-2022 | 09-24-2021 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01 | SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration. | Eli Lilly & Company / 19,174 syringes | Class I | Terminated |
| D-0855-2021 | 09-23-2021 | Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01 Package NDCs: 69367-174-01 | Finished product specification did not meet USP specifications. | Monarch PCM, LLC / 11,419 tubes | Class II | Terminated |
| D-0899-2021 | 09-22-2021 | Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213 | Lack of Assurance of Sterility | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy / 1,347 vials | Class II | Terminated |
| D-0007-2022 | 09-22-2021 | Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1 | Lack of Assurance of Sterility | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 385 bags | Class II | Terminated |
| D-0023-2022 | 09-22-2021 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 1,978 inhalers | Class II | Terminated |
| D-0025-2022 | 09-22-2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 5,500 inhalers | Class II | Terminated |
| D-0024-2022 | 09-22-2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 4,850 inhalers | Class II | Terminated |
| D-0022-2022 | 09-22-2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 3,240 inhalers | Class II | Terminated |
| D-0021-2022 | 09-22-2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 10,665 inhalers | Class II | Terminated |
| D-0898-2021 | 09-21-2021 | Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14 | Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing. | SigmaPharm Laboratories LLC / 1192 bottles | Class II | Terminated |
| D-0018-2022 | 09-21-2021 | Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3 | CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues. | Sanitor Corporation / unknown | Class II | Terminated |
| D-0020-2022 | 09-17-2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11) | Failed Dissolution Specifications: results were above specification. | American Health Packaging / 2,266 cartons | Class II | Terminated |
| D-0897-2021 | 09-17-2021 | ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1 | Lack of sterility assurance. | IntegraDose Compounding Services LLC / 589 bags | Class II | Terminated |
| D-0896-2021 | 09-17-2021 | ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1 | Lack of sterility assurance. | IntegraDose Compounding Services LLC / 2,614 syringes | Class II | Terminated |
| D-0856-2021 | 09-17-2021 | Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper Package NDCs: 63323-452-00; 63323-452-01; 63323-454-00; 63323-454-01; 63323-455-00; 63323-455-01; 63323-458-00; 63323-458-01; 63323-451-00; 63323-451-01 | Defective container: Cracked vials leading to lack of sterility assurance | Fresenius Kabi USA LLC / 963000 vials | Class II | Terminated |
| D-0854-2021 | 09-15-2021 | Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | American Health Packaging / 548 ccases | Class II | Terminated |
| D-0829-2021 | 09-14-2021 | Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30 | CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Direct Rx / 2 bottles | Class II | Terminated |
| D-0798-2021 | 09-13-2021 | Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 Package NDCs: 0378-3224-93; 0378-3224-77; 0378-3225-93; 0378-3225-77; 0378-3231-93; 0378-3231-77; 0378-3232-93; 0378-3232-77 | Failed Impurities/Degradation Specifications; out of specification for Related Compound | Viatris / 21,094 | Class III | Terminated |
| D-0019-2022 | 09-10-2021 | Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41 | Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT" | Piramal Critical Care, Inc. / 100 glass vials | Class II | Terminated |
| D-0799-2021 | 09-09-2021 | Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049 Package NDCs: 30142-810-72; 30142-810-43; 30142-810-45; 30142-810-14 | Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces | Vi-Jon, Inc. / 21,156 bottles | Class II | Terminated |
| D-0008-2022 | 09-09-2021 | Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01. | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts. | Jacobus Pharmaceutical Company Inc. / 2,324 bottles | Class I | Terminated |
| D-0812-2021 | 09-09-2021 | Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99 Package NDCs: 65862-062-01; 65862-062-99; 65862-063-60; 65862-063-01; 65862-063-99; 65862-064-60; 65862-064-01; 65862-064-99 | Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. | Aurobindo Pharma USA Inc. / 2,820 bottles | Class II | Terminated |
| D-0717-2022 | 09-08-2021 | TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30 Package NDCs: 58790-010-30 | Lack of Assurance of Sterility | Akorn, Inc. / 62,331 box | Class II | Terminated |
| D-0801-2021 | 09-03-2021 | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21 | Failed Impurities/Degradation Specifications | Meitheal Pharmaceuticals Inc / 1,160 ten-pack cartons | Class III | Terminated |
| D-0805-2021 | 09-03-2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17 | Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. | ICU Medical Inc / 2,112 Flexible Containers | Class I | Terminated |
| D-0814-2021 | 09-03-2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 116,400 bottles | Class II | Completed |
| D-0816-2021 | 09-03-2021 | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 38,748 bottles | Class II | Completed |
| D-0815-2021 | 09-03-2021 | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 14,904 bottles | Class II | Completed |
| D-0005-2022 | 09-02-2021 | Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01 | Labeling: Incorrect Instructions | RISING PHARMACEUTICALS / 1,344 bottles | Class II | Ongoing |
| D-0853-2021 | 09-02-2021 | CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 | Subpotent Drug | New Vision Pharmaceuticals LLC / 18,864 FG cartons | Class III | Terminated |
| D-0852-2021 | 09-02-2021 | Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Subpotent Drug | New Vision Pharmaceuticals LLC / 14,976 FG cartons | Class III | Terminated |
| D-0817-2021 | 09-01-2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 | Subpotency: one product for active ingredient assay and another one for preservative assay | Monarch PCM, LLC / a) 3305 bottles; b) 840 bottles | Class III | Terminated |
| D-0818-2021 | 09-01-2021 | Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5 Package NDCs: 69367-174-01 | Subpotency: one product for active ingredient assay and another one for preservative assay | Monarch PCM, LLC / 6305 tubes | Class III | Terminated |
| D-0827-2021 | 08-27-2021 | Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35 | Lack of Assurance of Sterility | Glenmark Pharmaceuticals Inc., USA / a) 5362 inhalers; b) 5593 inhalers | Class II | Terminated |
| D-0824-2021 | 08-27-2021 | Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 4752 bottles | Class II | Terminated |
| D-0823-2021 | 08-27-2021 | Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 1800 bottles | Class II | Terminated |
| D-0830-2021 | 08-27-2021 | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC). | DuPont Nutrition USA, Inc / 80 kg | Class I | Terminated |
| D-0820-2021 | 08-27-2021 | Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32 Package NDCs: 68462-317-40; 68462-317-32 | Lack of Assurance of Sterility | Glenmark Pharmaceuticals Inc., USA / 28658 cartons | Class II | Terminated |
| D-0821-2021 | 08-27-2021 | Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 9552 bottles | Class II | Terminated |
| D-0822-2021 | 08-27-2021 | Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05 Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / a) 31248 bottles; b) 300 bottles | Class II | Terminated |
| D-0826-2021 | 08-27-2021 | Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / a) 216,454 bottles; b) 2166 bottles | Class II | Terminated |
| D-0825-2021 | 08-27-2021 | Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 15936 bottles | Class II | Terminated |
| D-0828-2021 | 08-26-2021 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03 Package NDCs: 67618-153-01; 67618-153-03 | Subpotent Drug | AVRIO HEALTH L.P / 75,828 shippers | Class II | Terminated |
| D-0003-2022 | 08-24-2021 | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05. Package NDCs: 65628-204-05; 65628-205-10; 65628-206-05; 65628-208-10 | Product Mix-up: Incorrect diluent component included in the kit. | Azurity Pharmaceuticals, Inc. / 2,751 kits | Class I | Terminated |
| D-0290-2022 | 08-24-2021 | Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06 Package NDCs: 58593-235-06; 58593-235-04; 58593-235-08; 58593-235-29; 58593-235-10 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 10,833 bottles | Class II | Terminated |
| D-0291-2022 | 08-24-2021 | Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06 Package NDCs: 58593-275-06; 58593-275-10; 58593-275-04; 58593-275-08 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 27,206 bottles | Class II | Terminated |
| D-0293-2022 | 08-24-2021 | Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08 Package NDCs: 58593-828-08 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 4,026 bottles | Class II | Terminated |
| D-0292-2022 | 08-24-2021 | Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166 Package NDCs: 58593-829-06; 58593-829-04 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / a) 7,800 bottles; b) 16,417 bottles | Class II | Terminated |
| D-0297-2022 | 08-23-2021 | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29 | Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing | Teligent Pharma, Inc. / 3,792 bottles | Class II | Terminated |
| D-0851-2021 | 08-23-2021 | Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01 | Failed Dissolution Specifications | Viatris / 9,515 bottles | Class II | Terminated |
| D-0887-2021 | 08-20-2021 | ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%, WHP Homeopathic Medicine, For Manufacturing Use Only; Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/liter | Class II | Terminated |
| D-0890-2021 | 08-20-2021 | Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 47537 9; (c) 1 oz, UPC 7 40640 47541 6; (d) 2 oz, UPC 7 40640 47545 4; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 91 bottles | Class II | Terminated |
| D-0873-2021 | 08-20-2021 | Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0874-2021 | 08-20-2021 | Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0784-2021 | 08-20-2021 | Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 14,544 bottles | Class III | Terminated |
| D-0891-2021 | 08-20-2021 | Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, packaged in 100mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0889-2021 | 08-20-2021 | Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 91 bottles | Class II | Terminated |
| D-0880-2021 | 08-20-2021 | Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter bottle | Class II | Terminated |
| D-0864-2021 | 08-20-2021 | Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 6 bottles | Class II | Terminated |
| D-0877-2021 | 08-20-2021 | Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
