Class I - Dangerous
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Valgene Incorporated
Class I - Dangerous
Lack of Processing Controls
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Preferred Pharmaceuticals
Class I - Dangerous
Defective container: Out of specification for container integrity leading to bottles leaking.
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Product Mix-up
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Crystallization: Product appears to be turbid.
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Failed dissolution specifications
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed dissolution specifications
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed dissolution specifications
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Temperature Abuse; temperature excursion during shipping
Class I - Dangerous
Lack of sterility assurance: bag has the potential to leak.
Class I - Dangerous
Lack of Assurance of Sterility
Subpotent Drug