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 April 12, 2024 and include a total of 16143 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | Ongoing |
| 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-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-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 |
| 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-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-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-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-0149-2024 | 11-20-2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66 Package NDCs: 0078-0670-66; 0078-1077-66 | Failed Dissolution Specifications | Siegfried Barbera, SL / 2016 | Class III | Ongoing |
| D-0220-2024 | 11-17-2023 | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53 Package NDCs: 69097-964-53 | Defective Container: powder may leak out of the pouch | InvaGen Pharmaceuticals, Inc. / 1240 boxes | Class I | Ongoing |
| D-0146-2024 | 11-14-2023 | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25 Package NDCs: 36000-012-25; 36000-013-01 | Failed pH Specifications | Baxter Healthcare Corporation / 6,022,675 vials | Class II | Ongoing |
| D-0299-2024 | 11-13-2023 | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1 | Non-Sterility | Kilitch Healthcare India Limited / 23,208 bottles | Class I | Ongoing |
| D-0305-2024 | 11-13-2023 | CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15 | Non-Sterility | Kilitch Healthcare India Limited / 45,408 bottles | Class I | Ongoing |
| D-0292-2024 | 11-13-2023 | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 137,784 bottles | Class I | Ongoing |
| D-0308-2024 | 11-13-2023 | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3 | Non-Sterility | Kilitch Healthcare India Limited / 9,216 bottles | Class I | Ongoing |
| D-0304-2024 | 11-13-2023 | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5 | Non-Sterility | Kilitch Healthcare India Limited / 6,024 bottles | Class I | Ongoing |
| D-0301-2024 | 11-13-2023 | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1 | Non-Sterility | Kilitch Healthcare India Limited / 14,784 bottles | Class I | Ongoing |
| D-0309-2024 | 11-13-2023 | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid | Non-Sterility | Kilitch Healthcare India Limited / 7,296 bottles | Class I | Ongoing |
| D-0310-2024 | 11-13-2023 | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94 | Non-Sterility | Kilitch Healthcare India Limited / 56,520 bottles | Class I | Ongoing |
| D-0298-2024 | 11-13-2023 | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 150,720 bottles | Class I | Ongoing |
| D-0293-2024 | 11-13-2023 | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94 | Non-Sterility | Kilitch Healthcare India Limited / 1,492,344 bottles | Class I | Ongoing |
| D-0302-2024 | 11-13-2023 | Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30 | Non-Sterility | Kilitch Healthcare India Limited / 2,820 bottles | Class I | Ongoing |
| D-0295-2024 | 11-13-2023 | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1 | Non-Sterility | Kilitch Healthcare India Limited / 12,960 bottles | Class I | Ongoing |
| D-0307-2024 | 11-13-2023 | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3 | Non-Sterility | Kilitch Healthcare India Limited / 7,776 bottles | Class I | Ongoing |
| D-0300-2024 | 11-13-2023 | Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403 | Non-Sterility | Kilitch Healthcare India Limited / 401,568 bottles | Class I | Ongoing |
| D-0306-2024 | 11-13-2023 | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5 | Non-Sterility | Kilitch Healthcare India Limited / 7,200 bottles | Class I | Ongoing |
| D-0294-2024 | 11-13-2023 | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10 | Non-Sterility | Kilitch Healthcare India Limited / 110,832 bottles | Class I | Ongoing |
| D-0303-2024 | 11-13-2023 | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01 | Non-Sterility | Kilitch Healthcare India Limited / 33,984 bottles | Class I | Ongoing |
| D-0311-2024 | 11-13-2023 | Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30 | Non-Sterility | Kilitch Healthcare India Limited / 137,544 bottles | Class I | Ongoing |
| D-0290-2024 | 11-13-2023 | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 386,256 bottles | Class I | Ongoing |
| D-0296-2024 | 11-13-2023 | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15 | Non-Sterility | Kilitch Healthcare India Limited / 253,080 bottles | Class I | Ongoing |
| D-0297-2024 | 11-13-2023 | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1 | Non-Sterility | Kilitch Healthcare India Limited / 10,944 bottles | Class I | Ongoing |
| D-0291-2024 | 11-13-2023 | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 | Non-Sterility | Kilitch Healthcare India Limited / 210,192 bottles | Class I | Ongoing |
| D-0143-2024 | 11-13-2023 | KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698. Package NDCs: 82673-096-02; 8500018056 | Failed Impurities/Degradation Specifications | KINDER FARMS LLC / 376,370 bottles | Class II | Ongoing |
| D-0142-2024 | 11-13-2023 | KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728. | Failed Impurities/Degradation Specifications | KINDER FARMS LLC / 591,684 bottles | Class II | Ongoing |
| D-0127-2024 | 11-10-2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30 Package NDCs: 0591-2924-18; 0591-2925-32; 0591-2925-30; 0591-2926-25; 0591-2926-30 | OOS for viscosity | Teva Pharmaceuticals USA, Inc / | Class III | Ongoing |
| D-0129-2024 | 11-10-2023 | PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 2502 bottles | Class II | Ongoing |
| D-0125-2024 | 11-10-2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01 | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper | Fagron Compounding Services / 756 bottles | Class III | Ongoing |
| D-0128-2024 | 11-10-2023 | PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 1941 bottles | Class II | Ongoing |
| D-0130-2024 | 11-10-2023 | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 5626 bottles | Class II | Ongoing |
| D-0106-2024 | 11-09-2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334. | cGMP Deviations | Family Medical Supply Inc / 26,657 Cylinders | Class II | Ongoing |
| D-0423-2024 | 11-09-2023 | SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 8,755 syringe | Class II | Ongoing |
| D-0409-2024 | 11-09-2023 | HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5392 syringes | Class II | Ongoing |
| D-0394-2024 | 11-09-2023 | Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 381 Bags | Class II | Ongoing |
| D-0397-2024 | 11-09-2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 242 bags | Class II | Ongoing |
| D-0415-2024 | 11-09-2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 7,198 syringes; expanded 1,289 syringes | Class II | Ongoing |
| D-0410-2024 | 11-09-2023 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 909 syringes | Class II | Ongoing |