Class II · Moderate risk Terminated
Azithromycin Tablets
Reason cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag
Reason 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 Terminated
Kabiven
Reason Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Class II · Moderate risk Terminated
Alinia
Reason Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk Terminated
Bi-Est
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Bi-Est
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Estradiol cream
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Bi-Est
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Estriol
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Bi-Est
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Estradiol
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Estradiol
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Tri-Est 80:10:10 Progesterone
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Methyl Folate Lyophilized Powder for Injection
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Artesunate Lyophilized Powder for Injection
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Meloxicam capsules
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Leucovorin Calcium capsules
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Bi-Est 80:20 Progesterone
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk Terminated
Ketorolac Trom 30 Mg/Ml Inj
Reason Crystallization
Class II · Moderate risk Terminated
Captopril Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Captopril Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Captopril Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Zonisamide Capsules
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Zonisamide Capsules
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.