Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
FDA Drug Recalls
6,161 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
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
0.9% Sodium Chloride Injection
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk
Clinimix E 5/20 sulfite-free
Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.