Class I - Dangerous
Failed Dissolution Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Ingenus Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
Dr. Reddy's Laboratories
Class I - Dangerous
Subpotent drug
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Stability Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Exela Pharma Sciences
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Defective Delivery System
Class I - Dangerous
Labeling: Missing Label
Class I - Dangerous
Labeling: Missing Label
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.