Class II · Moderate risk
PEPTIME Energy
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
PEPTIME Energy
cGMP deviations
Class II · Moderate risk
MAGNACAL (calcium carbonate 420 mg)
cGMP deviations
Class II · Moderate risk
PAPENOL (acetaminophen 500 mg)
cGMP deviations
Class II · Moderate risk
Regular Strength Pain Reliever
cGMP deviations
Class II · Moderate risk
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant
cGMP deviations
Class II · Moderate risk
Mint Flavored Antacid
cGMP deviations
Class II · Moderate risk
CONGESTAID II Nasal Decongestant
cGMP deviations
Class II · Moderate risk
PAINAID PMF Premenstrual Formula
cGMP deviations
Class II · Moderate risk
PAINAID BRF Back Relief Formula
cGMP deviations
Class II · Moderate risk
Painaid
cGMP deviations
Class II · Moderate risk
Extra Strength Un-Aspirin
cGMP deviations
Class II · Moderate risk
Dilotab II
cGMP deviations
Class II · Moderate risk
SINU-PHEN PLUS sinus pain and congestion tabs
cGMP deviations
Class II · Moderate risk
PAIN TERMINATOR extra strength pain relief
cGMP deviations
Class II · Moderate risk
COLD TERMINATOR decongestant/cold relief
cGMP deviations
Class II · Moderate risk
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant
cGMP deviations
Class II · Moderate risk
Pain Away Pain Reliever/Fever Reducer
cGMP deviations
Class II · Moderate risk
Headache & Congestion Sinus Relief
cGMP deviations
Class II · Moderate risk
Cold Relief
cGMP deviations
Class II · Moderate risk
Backache & Muscle Relief
cGMP deviations
Class II · Moderate risk
Multi-Symptom Cramp Relief
cGMP deviations
Class II · Moderate risk
Cold Relief Severe Pain/Cough
cGMP deviations
Class II · Moderate risk
Lite Remfresh Advanced Ion-Powered Melatonin
cGMP deviations
Class II · Moderate risk
Multi Symptom Cold Relief
cGMP deviations
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