Class II · Moderate risk Terminated
Ephedrine Plus
Reason cGMP deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
DBI 357 Super Magnum Quick Energy Stimulant
Reason cGMP deviations
Class II · Moderate risk Terminated
Cystex Urinary Pan Relief
Reason cGMP deviations
Class II · Moderate risk Terminated
Legatrin PM Pain Reliever/Sleep Aid
Reason cGMP deviations
Class II · Moderate risk Terminated
Extra Strength
Reason cGMP deviations
Class II · Moderate risk Terminated
Chloresin
Reason cGMP deviations
Class II · Moderate risk Terminated
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer
Reason cGMP deviations
Class II · Moderate risk Terminated
AERO TAB Cold Relief
Reason cGMP deviations
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 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 II · Moderate risk Terminated
Clobetasol Propionate Foam
Reason CGMP Deviations
Class II · Moderate risk Terminated
Clobazam Oral Suspension 2.5 mg/mL
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Sufentanil Citrate Injection
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets
Reason Complaint received of foreign matter (metal) embedded in tablet.
Class II · Moderate risk Terminated
Metformin 750 mg Extended Release NDC # 70518-2920-00
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.