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 May 03, 2024 and include a total of 16182 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0320-2024 | 02-01-2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11 Package NDCs: 68084-447-11; 68084-447-01 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. | Amerisource Health Services LLC / 2,850 cartons | Class III | Ongoing |
| D-0346-2024 | 02-01-2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3 | Chemical Contamination; presence of benzene. | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 59,644 cans | Class I | Ongoing |
| D-0318-2024 | 02-01-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle. | NATCO Pharma Limited / 4260 bottles | Class II | Ongoing |
| D-0351-2024 | 01-30-2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298 | Lack of Assurance of Sterility | Brassica Pharma Pvt Ltd / 315,842 units | Class II | Ongoing |
| D-0352-2024 | 01-30-2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304 | Lack of Assurance of Sterility | Brassica Pharma Pvt Ltd / 355,633 units | Class II | Ongoing |
| D-0354-2024 | 01-30-2024 | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356 Package NDCs: 71406-124-35; 3714061243 | Lack of Assurance of Sterility | Brassica Pharma Pvt Ltd / 355,120 units | Class II | Ongoing |
| D-0353-2024 | 01-30-2024 | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141 | Lack of Assurance of Sterility | Brassica Pharma Pvt Ltd / 159,334 units | Class II | Ongoing |
| D-0314-2024 | 01-25-2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 Package NDCs: 60687-538-11; 60687-538-21 | CGMP Deviations | Amerisource Health Services LLC / 1,932 cartons | Class II | Ongoing |
| D-0321-2024 | 01-25-2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67 Package NDCs: 0555-9009-80; 0555-9009-42; 0555-9010-79; 0555-9010-58; 0555-9008-79; 0555-9008-67 | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Teva Pharmaceuticals USA, Inc / 12,916 cartons | Class III | Ongoing |
| D-0322-2024 | 01-25-2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58 Package NDCs: 0555-9012-79; 0555-9012-58 | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Teva Pharmaceuticals USA, Inc / 19,824 cartons | Class III | Ongoing |
| D-0338-2024 | 01-25-2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562. | CGMP Deviations | Alpha Aromatics / 676 gallons | Class II | Ongoing |
| D-0336-2024 | 01-23-2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20 Package NDCs: 0338-0112-20; 0338-0108-20; 0338-0116-20 | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL. | Baxter Healthcare Corporation / 13,000 bags | Class II | Ongoing |
| D-0325-2024 | 01-22-2024 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1. | Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date. | IntegraDose Compounding Services LLC / 1,299 syringes | Class II | Ongoing |
| D-0332-2024 | 01-19-2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | CGMP Deviations: Potential Glass and Silicone particulates in product | Bestco LLC / a) 1597 cases/ 12 pack each b) 73 cases/4 pack each | Class II | Ongoing |
| D-0330-2024 | 01-19-2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | CGMP Deviations: Potential Glass and Silicone particulates in product | Bestco LLC / 21 cases/4 pack each | Class II | Ongoing |
| D-0288-2024 | 01-19-2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | CGMP Deviations | OMEZA LLC / 4390 vials | Class II | Ongoing |
| D-0289-2024 | 01-19-2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | CGMP Deviations | OMEZA LLC / 1210 vials | Class II | Ongoing |
| D-0331-2024 | 01-19-2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | CGMP Deviations: Potential Glass and Silicone particulates in product | Bestco LLC / 46 cases/6 pack each | Class II | Ongoing |
| D-0329-2024 | 01-19-2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | CGMP Deviations: Potential Glass and Silicone particulates in product | Bestco LLC / 16 cases/4 pack each | Class II | Ongoing |
| D-0328-2024 | 01-19-2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | CGMP Deviations: Potential Glass and Silicone particulates in product | Bestco LLC / 78 cases/18 packs each | Class II | Ongoing |
| D-0264-2024 | 01-18-2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83. Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 55,272 bottles | Class II | Ongoing |
| D-0312-2024 | 01-18-2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01 Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78 | Misprint on tablet | Dr. Reddy's Laboratories, Inc. / 59,336 bottles | Class III | Ongoing |
| D-0266-2024 | 01-18-2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83. Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 11,400 bottles | Class II | Ongoing |
| D-0263-2024 | 01-18-2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83. Package NDCs: 47335-379-83; 47335-380-83; 47335-600-83 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 1,728 bottles | Class II | Ongoing |
| D-0268-2024 | 01-18-2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13. Package NDCs: 63304-175-13 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 10,690 bottles | Class II | Ongoing |
| D-0272-2024 | 01-18-2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88. Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 14,568 bottles | Class II | Ongoing |
| D-0313-2024 | 01-18-2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05 Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78 | Misprint on tablet | Dr. Reddy's Laboratories, Inc. / 14,425 bottles | Class III | Ongoing |
| D-0267-2024 | 01-18-2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83. Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 9,408 bottles | Class II | Ongoing |
| D-0265-2024 | 01-18-2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83. Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 19,992 bottles | Class II | Ongoing |
| D-0271-2024 | 01-18-2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88. Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 1220 bottles | Class II | Ongoing |
| D-0273-2024 | 01-18-2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India. Package NDCs: 51660-998-30; 51660-998-55; 51316-800-90; 51316-800-70; 51316-800-45; 51316-800-30; 51316-800-15; 51316-800-08 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 54,504 bottles | Class II | Ongoing |
| D-0269-2024 | 01-18-2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81. Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 6552 bottles | Class II | Ongoing |
| D-0270-2024 | 01-18-2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81. Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 15,768 bottles | Class II | Ongoing |
| D-0342-2024 | 01-17-2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01 Package NDCs: 42023-159-01; 42023-159-25; 42023-168-01; 0404-9810-01 | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect. | Henry Schein Inc. and Glove Club HSI Gloves Inc. / 1,099 Single Dose Vials | Class II | Ongoing |
| D-0339-2024 | 01-16-2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57 Package NDCs: 67877-749-57 | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Ascend Laboratories, LLC / 71,244 sachets | Class II | Ongoing |
| D-0287-2024 | 01-16-2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436. | CGMP Deviations: products may not conform to the labeled specifications. | Den-Mat Holdings, LLC / 10,103 units | Class II | Ongoing |
| D-0286-2024 | 01-16-2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4. | CGMP Deviations: products may not conform to the labeled specifications. | Den-Mat Holdings, LLC / 344 tubes | Class II | Ongoing |
| D-0319-2024 | 01-15-2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01 | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Amneal Pharmaceuticals of New York, LLC / 858 bottles | Class II | Ongoing |
| D-0334-2024 | 01-12-2024 | Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Neptune Resources, LLC / 117,000 bottles | Class I | Ongoing |
| D-0335-2024 | 01-12-2024 | Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Neptune Resources, LLC / 4,932 boxes | Class I | Ongoing |
| D-0333-2024 | 01-12-2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Neptune Resources, LLC / 1,000,000 bottles | Class I | Ongoing |
| D-0285-2024 | 01-11-2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11 Package NDCs: 60687-575-11; 60687-575-21; 60687-586-11; 60687-586-01 | Failed Impurities/Degradation Specification. | Amerisource Health Services LLC / 1,568 cartons | Class II | Ongoing |
| D-0232-2024 | 01-11-2024 | Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10 Package NDCs: 42023-164-01; 42023-164-25; 42023-164-10; 42023-190-01; 42023-219-01; 42023-219-10; 42023-220-01; 42023-220-10; 42023-237-01; 42023-237-10; 42023-268-01; 42023-268-10 | Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. | Par Sterile Products LLC / 1721 cartons | Class II | Ongoing |
| D-0315-2024 | 01-10-2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44 Package NDCs: 53329-147-44 | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. | MEDLINE INDUSTRIES, LP - Northfield / 1,786 tubes | Class II | Ongoing |
| D-0262-2024 | 01-10-2024 | Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01. Package NDCs: 71839-104-01 | Lack of Sterility Assurance: Aseptic process simulation failure. | BE PHARMACEUTICALS AG / 22,176 Vials | Class II | Ongoing |
| D-0275-2024 | 01-08-2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30 Package NDCs: 0591-2510-30 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 10,672 30-count bottles | Class II | Ongoing |
| D-0283-2024 | 01-05-2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06 Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07 | Subpotent Drug and Failed Impurities/Degradation Specifications | Lupin Pharmaceuticals Inc. / 15,576 Bottles | Class II | Ongoing |
| D-0284-2024 | 01-05-2024 | Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06 Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07 | Subpotent Drug and Failed Impurities/Degradation Specifications | Lupin Pharmaceuticals Inc. / 165,60 bottles | Class II | Ongoing |
| D-0323-2024 | 01-04-2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03 Package NDCs: 24338-850-03; 24338-851-03; 24338-852-03; 24338-853-03; 24338-854-03; 24338-855-03; 24338-856-03 | Labeling: Label Mix-up | Azurity Pharmaceuticals, Inc. / 4,662 bottles | Class I | Ongoing |
| D-0259-2024 | 01-04-2024 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56 Package NDCs: 68462-185-56 | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol | Glenmark Pharmaceuticals Inc., USA / 38,496 bottles | Class II | Ongoing |
| D-0274-2024 | 01-03-2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-11; 68180-416-08; 68180-423-11; 68180-423-08 | Failed Impurities/Degradation Specifications | Lupin Pharmaceuticals Inc. / 4,608 Bottles | Class II | Ongoing |
| D-0223-2024 | 01-02-2024 | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10 | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Dr. Reddy's Laboratories, Inc. / 38,952 bottles | Class II | Ongoing |
| D-0237-2024 | 12-29-2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90 Package NDCs: 67877-626-90; 67877-626-01; 67877-626-05; 67877-626-06 | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine. | Ascend Laboratories, LLC / 3,288 bottles | Class II | Ongoing |
| D-0260-2024 | 12-29-2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16 Package NDCs: 64380-752-16 | Failed Dissolution Specifications | Strides Pharma Inc. / 396 50-count bottles | Class II | Ongoing |
| D-0222-2024 | 12-29-2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03 Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10 | Presence of Foreign Tablets/Capsules | Rising Pharma Holding, Inc. / 47,976 bottles | Class II | Ongoing |
| D-0280-2024 | 12-28-2023 | PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 12,564 IV bags | Class I | Ongoing |
| D-0282-2024 | 12-28-2023 | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 7,548 IV bags | Class I | Ongoing |
| D-0277-2024 | 12-28-2023 | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 8,976 IV bags | Class I | Ongoing |
| D-0279-2024 | 12-28-2023 | PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 29,016 IV bags | Class I | Ongoing |
| D-0215-2024 | 12-28-2023 | Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4. | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. / 4,176 bottles | Class II | Ongoing |
| D-0216-2024 | 12-28-2023 | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7. Package NDCs: 63868-605-01; 63868-676-01 | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. / 7,992 bottles | Class II | Ongoing |
| D-0214-2024 | 12-28-2023 | Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8. Package NDCs: 63868-607-01 | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. / 7,992 bottles | Class II | Ongoing |
| D-0217-2024 | 12-28-2023 | Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0 Package NDCs: 63868-608-01 | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. / 8,160 bottles | Class II | Ongoing |
| D-0278-2024 | 12-28-2023 | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 13,920 IV bags | Class I | Ongoing |
| D-0281-2024 | 12-28-2023 | VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Denver Solutions, LLC DBA Leiters Health / 10,152 IV bags | Class I | Ongoing |
| D-0218-2024 | 12-28-2023 | DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62. Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52 | Lack of Sterility Assurance | Fresenius Medical Care Holdings, Inc. / 69,590 bags | Class II | Ongoing |
| D-0317-2024 | 12-26-2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 | Microbial Contamination of Non-Sterile Products | Haleon US Holdings LLC / 21,900 bottles | Class I | Ongoing |
| D-0316-2024 | 12-26-2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 | Microbial Contamination of Non-Sterile Products | Haleon US Holdings LLC / a) 31,632 bottles; b) 336,528 bottles | Class I | Ongoing |
| D-0257-2024 | 12-26-2023 | Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11 Package NDCs: 68084-214-11; 68084-214-01 | Superpotent drug: Assay results were slightly above specification at the time zero point. | Amerisource Health Services LLC / 6,344 cartons | Class III | Ongoing |
| D-0426-2024 | 12-26-2023 | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10 Package NDCs: 65162-755-10; 65162-755-50; 65162-757-10; 65162-757-50 | Failed dissolution specifications | Amneal Pharmaceuticals of New York, LLC / 21,452/100 count bottles | Class II | Ongoing |
| D-0233-2024 | 12-21-2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case). Package NDCs: 0409-5534-24; 0409-5534-14 | Presence of Particulate Matter; identified as glass | Pfizer Inc. / 34000 Cartons | Class I | Ongoing |
| D-0229-2024 | 12-21-2023 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, 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 / 13,344 bottles | Class II | Ongoing |
| D-0235-2024 | 12-21-2023 | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case). Package NDCs: 0409-1630-15; 0409-1630-10; 0409-9630-15; 0409-9630-05; 0409-4910-11; 0409-4910-34; 0409-4911-11; 0409-4911-34 | Presence of Particulate Matter; identified as glass | Pfizer Inc. / 24400 Cartons | Class I | Ongoing |
| D-0261-2024 | 12-21-2023 | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18 Package NDCs: 61703-323-22; 61703-332-18 | Presence of particulate matter: glass | PFIZER / 3,546 vials | Class I | Ongoing |
| D-0230-2024 | 12-21-2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10. Package NDCs: 82645-311-10 | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Pharma Nobis LLC / 53,268 Bottles | Class II | Ongoing |
| D-0227-2024 | 12-21-2023 | Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38 Package NDCs: 46122-741-38 | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Pharma Nobis LLC / 24,684 Bottles | Class II | Ongoing |
| D-0236-2024 | 12-21-2023 | Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7 Package NDCs: 63736-378-02 | Chemical Contamination: presence of benzene | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 34,704 cans | Class I | Ongoing |
| D-0234-2024 | 12-21-2023 | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case). Package NDCs: 0409-4916-24; 0409-4916-14; 0409-6637-24; 0409-6637-14 | Presence of Particulate Matter; identified as glass | Pfizer Inc. / 21200 Cartons | Class I | Ongoing |
| D-0231-2024 | 12-21-2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10. Package NDCs: 82645-312-10 | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Pharma Nobis LLC / 7,404 Bottles | Class II | Ongoing |
| D-0228-2024 | 12-21-2023 | Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98. Package NDCs: 0363-0427-98 | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Pharma Nobis LLC / 49,716 Bottles | Class II | Ongoing |
| D-0221-2024 | 12-20-2023 | Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202. Package NDCs: 68180-153-01; 68180-153-03; 68180-153-06; 68180-153-02; 68180-153-11; 68180-153-12 | CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. | Lupin Pharmaceuticals Inc. / 100=29,184 bottles; 500=2922 bottles | Class II | Ongoing |
| D-0219-2024 | 12-15-2023 | Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01 Package NDCs: 55111-525-30; 55111-525-01; 55111-525-05; 55111-525-79; 55111-525-78; 55111-526-30; 55111-526-01; 55111-526-05; 55111-526-79; 55111-526-78; 55111-527-30; 55111-527-01; 55111-527-05; 55111-527-79; 55111-527-78 | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. | Dr. Reddy's Laboratories, Inc. / 8,280 bottles | Class II | Ongoing |
| D-0152-2024 | 12-13-2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06. | CGMP Deviations: Stability data does not support expiry date. | Private Label Partners, Inc. / 3,396 bottles | Class II | Ongoing |
| D-0160-2024 | 12-12-2023 | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10 Package NDCs: 0173-0869-10; 0173-0869-06; 0173-0869-61 | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | GlaxoSmithKline LLC / 67,508 inhalers | Class III | Ongoing |
| D-0154-2024 | 12-11-2023 | NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3 | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc / 13 containers | Class II | Ongoing |
| D-0156-2024 | 12-11-2023 | NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6 | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc / 9 containers | Class II | Ongoing |
| D-0157-2024 | 12-11-2023 | NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5 | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc / 52 containers | Class II | Ongoing |
| D-0155-2024 | 12-11-2023 | NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9 | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Fagron, Inc / 46 containers | Class II | Ongoing |
| D-0205-2024 | 12-11-2023 | Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54 Package NDCs: 68645-521-54; 68645-522-54; 68645-523-54 | CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. | Legacy Pharmaceutical Packaging LLC / 161,664 bottles | Class II | Ongoing |
| D-0213-2024 | 12-08-2023 | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1 Package NDCs: 52652-9001-1; 52652-9001-2; 52652-9001-3 | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months. | Azurity Pharmaceuticals, Inc. / 2,220 bottles | Class III | Terminated |
| D-0150-2024 | 12-04-2023 | Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88 Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18 | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 96,192 bottles | Class II | Ongoing |
| D-0206-2024 | 11-29-2023 | Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ | Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil. | Meta Herbal / 500 blister packs | Class I | Ongoing |
| D-0147-2024 | 11-29-2023 | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26, | STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks. | STAQ Pharma, Inc. / 2616 bags | Class II | Ongoing |
| D-0204-2024 | 11-22-2023 | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3. | Presence of Particulate Matter. | AnazaoHealth Corporation / 3,363 vials | Class II | Ongoing |
| D-0141-2024 | 11-22-2023 | ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10 | Lack of assurance of sterility. | Wells Pharma of Houston LLC / 825 syringes | Class II | Ongoing |
| D-0151-2024 | 11-22-2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611. | Chemical Contamination; presence of benzene. | Insight Pharmaceuticals Corporation / 117,336 cans | Class I | Ongoing |
| D-0203-2024 | 11-22-2023 | B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3 | Presence of Particulate Matter. | AnazaoHealth Corporation / 5,707 vials | Class II | Ongoing |
| D-0148-2024 | 11-22-2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 Package NDCs: 70748-153-01 | Failed Dissolution Specifications | Lupin Pharmaceuticals Inc. / | Class II | Ongoing |
| D-0144-2024 | 11-22-2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22 Package NDCs: 0078-0240-61; 0078-0240-15; 0078-0241-61; 0078-0241-15; 0078-0109-61; 0078-0109-01; 0078-0110-22 | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Novartis Pharmaceuticals Corporation / 6,997 bottles | Class I | Ongoing |
| D-0137-2024 | 11-22-2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 2016 Bottles | Class III | Ongoing |