Class II · Moderate risk
Cetafen Non-aspirin pain reliever
cGMP deviations
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
Back Pain-Off
cGMP deviations
Class II · Moderate risk
MidNite Sleep Health
cGMP deviations
Class II · Moderate risk
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Class II · Moderate risk
DBI 357 Super Magnum Quick Energy Stimulant
cGMP deviations
Class II · Moderate risk
Cystex Urinary Pan Relief
cGMP deviations
Class II · Moderate risk
Legatrin PM Pain Reliever/Sleep Aid
cGMP deviations
Class II · Moderate risk
Extra Strength
cGMP deviations
Class II · Moderate risk
Chloresin
cGMP deviations
Class II · Moderate risk
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer
cGMP deviations
Class II · Moderate risk
AERO TAB Cold Relief
cGMP deviations
Class II · Moderate risk
Class II · Moderate risk
Nasal & Sinus Decongestant
cGMP deviations
Class II · Moderate risk
Proctofoam HC
cGMP deficiencies
Class II · Moderate risk
Lexette (halobetasol propionate)
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk
Lung Cleaner
cGMP deviations
Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCl Oral Solution
CGMP Deviations
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Class II · Moderate risk
Vitamin K (Vitamin K)
CGMP Deviations
Class II · Moderate risk
Lidocaine HCl/Phenylephrine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Phenol
CGMP Deviations
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