Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
FDA Drug Recalls
18,003 recalls, newest first
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 III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
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 III · Low risk
QVAR (beclomethasone dipropionate HFA 40 mcg)
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Loratadine Orally Disintegrating Tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
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.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Ortho-Cept
Subpotent Drug
Class II · Moderate risk
Azithromycin 500 mg tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.