Class II · Moderate risk
Trimix (A;ph,pa)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 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
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.
Class II · Moderate risk
Kabiven
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids