Class II · Moderate risk Terminated
Glycerin
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Glutathione 200mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol Valerate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol Valerate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol Cypionate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyanocobalamin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MD-Gastroview
Reason Labeling: incorrect or missing lot number and/or expiration date
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Hyaluronidase
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Glutathione INHALATION
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Glutathione INHALATION
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Bimix
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Avastin
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk Terminated
Famotidine Tablets
Reason CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Class II · Moderate risk Terminated
Zebeta¿
Reason Failed Dissolution Specifications: OOS result during stability testing
Class II · Moderate risk Terminated
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Reason Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk Terminated
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Reason Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk Terminated
Ortho-Cept
Reason Subpotent Drug
Class II · Moderate risk Terminated
Azithromycin 500 mg tablets
Reason cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.