Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
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.
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
Class II · Moderate risk
Alinia (nitazoxanide)
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol cream
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.