Class II · Moderate risk Terminated
AERO TAB Cold Relief
Reason cGMP deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant
Reason cGMP deviations
Class II · Moderate risk Terminated
Nasal & Sinus Decongestant
Reason cGMP deviations
Class II · Moderate risk Terminated
Proctofoam HC
Reason cGMP deficiencies
Class III · Low risk Terminated
Bortezomib
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class II · Moderate risk Terminated
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release…
Reason Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Lexette
Reason CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
Lung Cleaner
Reason cGMP deviations
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tretinoin Capsules
Reason Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III · Low risk Terminated
Mucus Relief D
Reason Subpotent drug
Class II · Moderate risk Terminated
Clobetasol Propionate Foam
Reason CGMP Deviations
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class II · Moderate risk Terminated
Clobazam Oral Suspension 2.5 mg/mL
Reason Failed Stability Specifications
Class I · High risk Terminated
Semglee
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class II · Moderate risk Terminated
Sufentanil Citrate Injection
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class III · Low risk Terminated
Leader
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
CVS Health
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Qc Quality Choice
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
equate
Reason Failed Dissolution Specifications