Drug Recalls
RSS ↗2,059 drug recalls from federal enforcement feeds.
Showing 1,501–1,550 of 2,059
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9cGMP Deviations
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimorCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimoCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Drug Recall · October 23, 2024
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Drug Recall · October 23, 2024
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.Failed Impurities/Degradation Specification
- Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.Failed Impurities/Degradation Specification
- Class II
Drug Recall · October 21, 2024
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24Superpotent Drug: Stability failure for assay at 6 months test time-point.
- Class II
Drug Recall · October 18, 2024
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28Labeling: Label Mix-Up
- Class II
Drug Recall · October 18, 2024
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28Labeling: Label Mix-Up
- Class III
Drug Recall · October 11, 2024
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
- Class II
Drug Recall · October 10, 2024
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured bCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Drug Recall · October 10, 2024
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. ManufacturedCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Drug Recall · October 10, 2024
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. ManufacturedCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Drug Recall · October 10, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Class II
Drug Recall · October 9, 2024
Dr. Reddy's Laboratories, Inc.
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Class II
Drug Recall · October 9, 2024
Dr. Reddy's Laboratories, Inc.
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Class II
Drug Recall · October 9, 2024
Dr. Reddy's Laboratories, Inc.
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Class II
Drug Recall · October 8, 2024
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01CGMP violations.
- Class II
Drug Recall · October 8, 2024
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
- Class II
Drug Recall · October 8, 2024
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02CGMP violations.
- Class II
Drug Recall · October 1, 2024
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals LFailed Impurities/Degradation Specifications.
- Class III
Drug Recall · September 30, 2024
Glenmark Pharmaceuticals Inc., USA
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: GDefective Container: Firm received complaints of broken tube at the seal.
- Class I
Drug Recall · September 30, 2024
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317Presence of Particulate Matter: Presence of glass particulates.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58cGMP violations
- Class III
Drug Recall · September 25, 2024
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56cGMP violations
- Class III
Drug Recall · September 25, 2024
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58CGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58cGMP violations
- Class II
Drug Recall · September 24, 2024
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., VaPresence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
- Class II
Drug Recall · September 24, 2024
Glenmark Pharmaceuticals Inc., USA
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43Defective Delivery System: The dip tube is clogged causing the spray not to work.
- Class II
Drug Recall · September 24, 2024
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.Crystallization
- Class I
Drug Recall · September 19, 2024
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2Presence of Particulate Matter: Presence of glass particle.
- Class II
Drug Recall · September 18, 2024
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1CGMP deviations
- Class I
Drug Recall · September 18, 2024
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.