Class II · Moderate risk
Lung Cleaner
cGMP deviations
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Class II · Moderate risk
Clobazam Oral Suspension 2.5 mg/mL
Failed Stability Specifications
Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.