Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class II · Moderate risk
Testosterone Cypionate Testosterone Propionate
Lack of Assurance of Sterility
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Cleaning Solutions Foaming Hand Sanitizer
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk
ceFAZolin 3 G in 0.9% Sodium Chloride
Lack of sterility assurance.
Class II · Moderate risk
ceFAZolin
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate Injection
Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.