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 July 04, 2025 and include a total of 16930 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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 | Completed |
| 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 | Completed |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | Ongoing |
| 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 | 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-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-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-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 | Ongoing |
| 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-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-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-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 | Ongoing |
| 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-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-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-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 |
| 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-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-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-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-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-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-0495-2024 | 04-12-2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 | cGMP Deviations | Dercher Enterprises, Inc., DBA Gordon Laboratories / 5,247 glass jars | Class II | Completed |
| D-0478-2024 | 04-10-2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01 | Out of specification for assay | Imprimis NJOF, LLC / 15,414 units | Class III | Ongoing |
| D-0476-2024 | 04-10-2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08 | Subpotent Drug | Imprimis NJOF, LLC / 3320 bottles | Class II | Ongoing |
| D-0469-2024 | 04-09-2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0467-2024 | 04-09-2024 | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc. Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0468-2024 | 04-09-2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0466-2024 | 04-09-2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / 108,192/30 count bottles or 7 count blister packs | Class III | Ongoing |
| D-0486-2024 | 04-08-2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30. | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 2402 cartons | Class I | Ongoing |
| D-0485-2024 | 04-08-2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. Package NDCs: 43598-097-11; 43598-097-30 | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 17,332 cartons | Class I | Ongoing |
| D-0434-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1332 vials | Class III | Ongoing |
| D-0433-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1283 vials | Class III | Ongoing |
| D-0461-2024 | 03-29-2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 Package NDCs: 0498-0631-37 | CGMP Deviations | HONEYWELL INC / 10, 605 cartridges | Class II | Terminated |
| D-0444-2024 | 03-28-2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. Package NDCs: 50268-086-11; 50268-086-12 | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | AvKARE / 153 cartons | Class I | Terminated |
| D-0439-2024 | 03-28-2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Teva Pharmaceuticals USA, Inc / 5,304 3x10-cartons | Class II | Ongoing |
| D-0441-2024 | 03-27-2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 Package NDCs: 72426-818-03; 72426-818-09; 72426-818-99 | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. | Esperion / 3,480 30-count bottles | Class III | Completed |
| D-0438-2024 | 03-27-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 | CGMP Deviations | NATCO Pharma Limited / 30 bottles | Class II | Ongoing |
| D-0471-2024 | 03-26-2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53 Package NDCs: 69097-173-64; 69097-173-53 | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. / 59244/3ml FFS packs | Class II | Completed |
| D-0430-2024 | 03-26-2024 | 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: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. | Glenmark Pharmaceuticals Inc., USA / 6,528 bottles | Class II | Ongoing |
| D-0443-2024 | 03-25-2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10 | Failed Impurities/Degradation Specifications | Novitium Pharma LLC / 1,003 bottles | Class III | Terminated |
| D-0477-2024 | 03-25-2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. Package NDCs: 69238-1605-2; 69238-1605-8 | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC / 2784 bottles | Class II | Completed |
| D-0459-2024 | 03-23-2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 9,625 bottles | Class I | Ongoing |
| D-0460-2024 | 03-23-2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5 | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 5299 bottles | Class I | Ongoing |
| D-0431-2024 | 03-22-2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00 Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Lack of assurance of sterility: bags have the potential to leak.. | B. Braun Medical Inc / 7,800 bags | Class II | Completed |
| D-0432-2024 | 03-22-2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1 | Lack of Assurance of Sterility: leaking bags | IntegraDose Compounding Services LLC / 187 cassettes | Class II | Ongoing |
| D-0427-2024 | 03-21-2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01 Package NDCs: 52925-112-01; 52925-112-25 | cGMP Diviations | Apothecus Pharmaceutical Corp. / 17,280 paper cartons | Class II | Terminated |
| D-0442-2024 | 03-21-2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 Package NDCs: 69238-2261-3; 69238-2261-7; 69238-2261-5 | Superpotent Drug: Due to overfilling of drug powder | Amneal Pharmaceuticals of New York, LLC / 821 bottles | Class I | Completed |
| D-0437-2024 | 03-21-2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06 | Subpotent Drug | Lupin Pharmaceuticals Inc. / 26,352 bottles | Class II | Terminated |
| D-0449-2024 | 03-19-2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0458-2024 | 03-19-2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0454-2024 | 03-19-2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 7 boxes | Class I | Ongoing |
| D-0450-2024 | 03-19-2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / N/A | Class I | Ongoing |
