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 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0152-2021 | 11-17-2020 | H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01 Package NDCs: 37808-305-01 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / N/A | Class II | Terminated |
| D-0105-2021 | 11-17-2020 | DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05 Package NDCs: 63323-883-05; 63323-883-10; 63323-883-30; 63323-101-61 | Cross Contamination with Other Products: trace amounts of octreotide found during testing | Fresenius Kabi USA, LLC / 16,986 vials | Class III | Terminated |
| D-0155-2021 | 11-17-2020 | Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01 Package NDCs: 30142-510-01 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 45,396 units | Class II | Terminated |
| D-0150-2021 | 11-17-2020 | CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03 Package NDCs: 59779-305-01; 59779-305-02; 59779-305-03 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 64,692 1 oz tubes | Class II | Terminated |
| D-0112-2021 | 11-17-2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30 | FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets | Golden State Medical Supply Inc. / 11,922 bottles | Class II | Terminated |
| D-0120-2021 | 11-17-2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05 Package NDCs: 63323-671-02; 63323-671-20; 63323-671-05; 63323-671-50; 63323-671-01; 63323-671-00 | Cross Contamination with other products: trace amounts of lidocaine | Fresenius Kabi USA, LLC / 13,525 bottles | Class I | Terminated |
| D-0118-2021 | 11-17-2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03 Package NDCs: 66977-107-03 | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia. | MPM Medical LLC / 7,637 tubes | Class I | Terminated |
| D-0153-2021 | 11-17-2020 | Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 30,816 1 oz tubes | Class II | Terminated |
| D-0149-2021 | 11-17-2020 | Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden | Cross contamination: the excipient was found to be contaminated with theophylline. | BASF Corporation / 4560 kg | Class II | Completed |
| D-0159-2021 | 11-17-2020 | Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 40,896 1 oz tube | Class II | Terminated |
| D-0156-2021 | 11-17-2020 | RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 34,920 0.5 oz tubes | Class II | Terminated |
| D-0157-2021 | 11-17-2020 | Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 11,088 1 oz tubes | Class II | Terminated |
| D-0115-2021 | 11-11-2020 | Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30 | Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing. | InvaTech Pharma Solutions, LLC / N/A | Class III | Terminated |
| D-0100-2021 | 11-11-2020 | Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Superpotent Drug: High out-of-specification assay results were obtained during stability testing. | Teva Pharmaceuticals USA / 12,088 cartons | Class III | Terminated |
| D-0106-2021 | 11-11-2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 | Failed Dissolution Specifications: Out of specification for dissolution. | Apotex Corp. / a)552 bottles; b) 3192 bottles | Class II | Terminated |
| D-0109-2021 | 11-10-2020 | Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52 | Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. | EYWA PHARMA INC / 5451 bottles | Class II | Terminated |
| D-0104-2021 | 11-06-2020 | clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30 | Failed Tablet/Capsule Specification | Jubilant Cadista Pharmaceuticals, Inc. / 4,416 bottles | Class II | Terminated |
| D-0119-2021 | 11-05-2020 | Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60 | Superpotent and Subpotent; low and high assay results | Teligent Pharma, Inc. / 20160 tubes | Class III | Terminated |
| D-0110-2021 | 11-03-2020 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59 | Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. | Teligent Pharma, Inc. / 4008 units | Class III | Terminated |
| D-0101-2021 | 11-03-2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25. Package NDCs: 0641-0497-17; 0641-0497-25; 0641-6144-01; 0641-6144-25 | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. | Hikma Pharmaceuticals USA Inc. / 2,100,646 Vials | Class II | Terminated |
| D-0077-2021 | 11-01-2020 | Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc. | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Preferred Pharmaceuticals, Inc. / 99 bottles (9990 Extended Release Tablets) | Class II | Terminated |
| D-0070-2021 | 10-30-2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12 | Failed Dissolution Specifications | AVKARE Inc. / 15,678 bottles | Class II | Terminated |
| D-0111-2021 | 10-28-2020 | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15 | Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata. | Lohxa LLC / 329 cartons | Class I | Terminated |
| D-0069-2021 | 10-28-2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22. Package NDCs: 0591-2245-22 | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA / 133,829 bottles | Class II | Terminated |
| D-0103-2021 | 10-27-2020 | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc. | Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. | Sunstar Americas, Inc. / a) 116,662 bottles; b) 13,296 bottles | Class I | Completed |
| D-0075-2021 | 10-27-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specification | Zydus Pharmaceuticals (USA) Inc / 7,908 units | Class II | Terminated |
| D-0074-2021 | 10-27-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specification | Zydus Pharmaceuticals (USA) Inc / 6,840 units | Class II | Terminated |
| D-0066-2021 | 10-26-2020 | Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 23,616 blister packs | Class III | Terminated |
| D-0097-2021 | 10-26-2020 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01 | Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg. | Ascent Pharmaceuticals, Inc. / 9768 Bottles | Class II | Terminated |
| D-0067-2021 | 10-23-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01 Package NDCs: 29033-055-01; 29033-055-05; 29033-055-10; 29033-056-01; 29033-056-10 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc / 12,967 bottles | Class II | Ongoing |
| D-0068-2021 | 10-23-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 Package NDCs: 29033-055-01; 29033-055-05; 29033-055-10; 29033-056-01; 29033-056-10 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc / 20,872 bottles | Class II | Ongoing |
| D-0108-2021 | 10-23-2020 | Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01 Package NDCs: 23155-048-01; 23155-048-05; 23155-049-01; 23155-049-05; 23155-050-01; 23155-050-05 | Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A | Heritage Pharmaceuticals Inc / 7176 bottles | Class III | Terminated |
| D-0065-2021 | 10-22-2020 | Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92 Package NDCs: 79395-003-92 | Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. | Aurobindo Pharma USA Inc. / 7440 bottles | Class III | Terminated |
| D-0072-2021 | 10-21-2020 | White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 | CGMP Deviations | H & H Remedies, LLC / 365 bottles | Class II | Terminated |
| D-0073-2021 | 10-21-2020 | Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 | CGMP Deviations | H & H Remedies, LLC / 252 jars | Class II | Terminated |
| D-0071-2021 | 10-21-2020 | Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 | CGMP Deviations | H & H Remedies, LLC / 939 jars | Class II | Terminated |
| D-0058-2021 | 10-12-2020 | Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90 Package NDCs: 72189-150-90; 72189-150-30; 72189-064-90; 72189-064-30 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | Direct Rx / 88 bottles | Class II | Terminated |
| D-0050-2021 | 10-11-2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | RemedyRepack Inc. / 79/30 count blister cards | Class II | Terminated |
| D-0087-2021 | 10-09-2020 | DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947 | GMP Deviations | Milbar Laboratories, Inc. / 1,225 bottles | Class II | Terminated |
| D-0084-2021 | 10-09-2020 | DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853 | GMP Deviations | Milbar Laboratories, Inc. / 7,591 bottles | Class II | Terminated |
| D-0092-2021 | 10-09-2020 | Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226 | GMP Deviations | Milbar Laboratories, Inc. / 4,855 tubes | Class II | Terminated |
| D-0093-2021 | 10-09-2020 | Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads | GMP Deviations | Milbar Laboratories, Inc. / 2,638 plastic jars | Class II | Terminated |
| D-0090-2021 | 10-09-2020 | (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001 | GMP Deviations | Milbar Laboratories, Inc. / 3,692 tubes | Class II | Terminated |
| D-0091-2021 | 10-09-2020 | MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN | GMP Deviations | Milbar Laboratories, Inc. / 2,655 bottles | Class II | Terminated |
| D-0086-2021 | 10-09-2020 | DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120 | GMP Deviations | Milbar Laboratories, Inc. / 1,815 bottles | Class II | Terminated |
| D-0094-2021 | 10-09-2020 | DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | GMP Deviations | Milbar Laboratories, Inc. / 2,335 bottles | Class II | Terminated |
| D-0085-2021 | 10-09-2020 | DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471 | GMP Deviations | Milbar Laboratories, Inc. / 1,608 bottles | Class II | Terminated |
| D-0096-2021 | 10-09-2020 | Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics | GMP Deviations | Milbar Laboratories, Inc. / 198.8 kg | Class II | Terminated |
| D-0089-2021 | 10-09-2020 | (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001 | GMP Deviations | Milbar Laboratories, Inc. / 2,664 tubes | Class II | Terminated |
| D-0095-2021 | 10-09-2020 | DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | GMP Deviations | Milbar Laboratories, Inc. / 927 tubes | Class II | Terminated |
| D-0088-2021 | 10-09-2020 | (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001 | GMP Deviations | Milbar Laboratories, Inc. / 5,312 bottles | Class II | Terminated |
| D-0083-2021 | 10-09-2020 | DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627 | GMP Deviations | Milbar Laboratories, Inc. / 4,878 tubes | Class II | Terminated |
| D-0302-2021 | 10-09-2020 | N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023 | Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. | Jarrow Formulas Inc / 533 units | Class II | Terminated |
| D-0044-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 13536 bottles | Class III | Terminated |
| D-0047-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 6780 bottles | Class III | Terminated |
| D-0048-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 34968 bottles | Class III | Terminated |
| D-0043-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 408 bottles | Class III | Terminated |
| D-0046-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 24972 bottles | Class III | Terminated |
| D-0045-2021 | 10-09-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10 Package NDCs: 43975-277-10; 43975-278-10; 43975-279-10; 43975-280-10; 43975-282-10; 43975-281-10 | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. / 13248 bottles | Class III | Terminated |
| D-0057-2021 | 10-08-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | Denton Pharma, Inc. / a) 684; b) 432; c) 3668; d) 2029 bottles | Class II | Ongoing |
| D-0056-2021 | 10-08-2020 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | Denton Pharma, Inc. / N/A | Class II | Ongoing |
| D-0076-2021 | 10-07-2020 | Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10 | Presence of particulate matter in solution - black and transparent particles | Baxter Healthcare Corporation / | Class II | Terminated |
| D-0042-2021 | 10-06-2020 | Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22 Package NDCs: 0781-6172-22; 0781-6172-86 | DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. | eVenus Pharmaceutical Laboratories / 9210 units | Class III | Terminated |
| D-0059-2021 | 10-06-2020 | metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 Package NDCs: 72789-009-30; 72789-009-60; 72789-009-90; 72789-009-93 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | PD-Rx Pharmaceuticals, Inc. / 1683 bottles | Class II | Terminated |
| D-0060-2021 | 10-06-2020 | metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60 Package NDCs: 43063-902-30; 43063-902-60 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | PD-Rx Pharmaceuticals, Inc. / 125 bottles | Class II | Terminated |
| D-0709-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 42 mL | Class I | Terminated |
| D-0052-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0710-2021 | 10-05-2020 | MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.8MG/ML, l) 30MG-10MG/ML, m) 5MG-4MG/ML, n) 10MG/ML-20MG/ML, o) 40MG-5MG/ML, p) 20MG-20MG/ML, q) 30MG-20MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 466 mL | Class I | Terminated |
| D-0716-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0707-2021 | 10-05-2020 | FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0713-2021 | 10-05-2020 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0706-2021 | 10-05-2020 | FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0708-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 126 mL | Class I | Terminated |
| D-0717-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 360 mL | Class I | Terminated |
| D-0712-2021 | 10-05-2020 | MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0715-2021 | 10-05-2020 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0711-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 84 mL | Class I | Terminated |
| D-0704-2021 | 10-05-2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0705-2021 | 10-05-2020 | BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 41 mL | Class I | Terminated |
| D-0051-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / 13,270 bottles/100 tablets each | Class II | Terminated |
| D-0053-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0714-2021 | 10-05-2020 | SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 41 mL | Class I | Terminated |
| D-0055-2021 | 10-02-2020 | Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 | Discoloration. | Medichem S.A. / 60,000 kg | Class II | Terminated |
| D-0062-2021 | 10-02-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / 368,976 bottles | Class II | Terminated |
| D-0061-2021 | 10-02-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles | Class II | Terminated |
| D-0049-2021 | 10-02-2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3001-77; 0378-3001-05; 0378-3002-77; 0378-3002-05; 0378-3003-77; 0378-3003-05 | Out-of-specification organic impurity results obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 10,695 bottles | Class III | Terminated |
| D-0098-2021 | 10-01-2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761 | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches | ASHTEL STUDIOS, INC. / N/A | Class I | Terminated |
| D-0064-2021 | 09-28-2020 | Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310 | Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. | Teligent Pharma, Inc. / 36,790 tubes | Class III | Terminated |
| D-0220-2021 | 09-25-2020 | Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 298 jars | Class I | Terminated |
| D-0218-2021 | 09-25-2020 | Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 46 jars | Class I | Terminated |
| D-0219-2021 | 09-25-2020 | Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 1651 jars | Class I | Terminated |
| D-0019-2021 | 09-25-2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816, | Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot | VistaPharm, Inc. / 14,244 16 oz bottles | Class III | Terminated |
| D-0034-2021 | 09-24-2020 | Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. | Leadiant Biosciences, Inc. / 1380 bottles | Class III | Terminated |
| D-0102-2021 | 09-24-2020 | SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 . | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | AA PRODUCTS INC / 1392 bottles | Class II | Completed |
| D-1626-2020 | 09-24-2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59 | Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. | Legacy Pharmaceutical Packaging LLC / 111,948 bottles | Class III | Terminated |
| D-0002-2021 | 09-23-2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17 | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | SUN PHARMACEUTICAL INDUSTRIES INC / 747 bottles | Class II | Terminated |
| D-0005-2021 | 09-17-2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01. | CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent. | PD-Rx Pharmaceuticals, Inc. / 20 bottles | Class II | Terminated |
| D-0035-2021 | 09-17-2020 | NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01 Package NDCs: 42192-327-01; 42192-327-30 | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. | Acella Pharmaceuticals, LLC / 19,296 bottles | Class I | Terminated |
| D-0099-2021 | 09-17-2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1. | Labeling: Product Contains Undeclared API; Incorrect formulation | Grato Holdings, Inc. / 399 bottles | Class III | Terminated |
| D-0036-2021 | 09-17-2020 | NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01 Package NDCs: 42192-328-30; 42192-328-01 | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. | Acella Pharmaceuticals, LLC / 9816 bottles | Class I | Terminated |
