Class II · Moderate risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason cGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Coppertone SPORT Sunscreen Spray 50
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone SPORT MINERAL 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class II · Moderate risk Ongoing
The Natural Dentist Healthy Balance Peppermint Sage
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class III · Low risk Ongoing
Butalbital
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk Ongoing
Butalbital
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class II · Moderate risk Terminated
Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Artesunate for Injection
Reason Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I · High risk Terminated
Glucagon Emergency Kit for Low Blood Sugar
Reason SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk Terminated
Hydroquinone USP
Reason Finished product specification did not meet USP specifications.
Class II · Moderate risk Terminated
Testosterone Cypionate Testosterone Propionate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 55/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Phenylbutyrate Powder
Reason Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk Terminated
Cleaning Solutions Foaming Hand Sanitizer
Reason CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk Terminated
ceFAZolin 3 G in 0.9% Sodium Chloride
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
ceFAZolin
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate Injection
Reason Defective container: Cracked vials leading to lack of sterility assurance