Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
GLYCERIN (Sterile Water)
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Valerate
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Valerate
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Cypionate
Lack of Assurance of Sterility
Class II · Moderate risk
Cyanocobalamin
Lack of Assurance of Sterility
Class II · Moderate risk
MD-Gastroview
Labeling: incorrect or missing lot number and/or expiration date
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (A;ph,pa)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (A;ph,pa)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Glutathione INHALATION
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Glutathione INHALATION
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Bimix (Phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Avastin
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Famotidine Tablets
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Class II · Moderate risk
Zebeta¿ (bisoprolol fumarate)
Failed Dissolution Specifications: OOS result during stability testing
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.