Class II · Moderate risk
Streptococcinum
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
Pyrogenium
cGMP deviations
Class II · Moderate risk
Proteus
cGMP deviations
Class II · Moderate risk
Pertussinum
cGMP deviations
Class II · Moderate risk
Morbillinum
cGMP deviations
Class II · Moderate risk
Medorrhinum
cGMP deviations
Class II · Moderate risk
Influenzinum
cGMP deviations
Class II · Moderate risk
Diphtherinum
cGMP deviations
Class II · Moderate risk
Colibacillinum
cGMP deviations
Class II · Moderate risk
Candida Parapsilosis
cGMP deviations
Class II · Moderate risk
Candida Albicans
cGMP deviations
Class II · Moderate risk
Bacillinum Pulmo
cGMP deviations
Class II · Moderate risk
Anthracinum
cGMP deviations
Class II · Moderate risk
Alcohol Antiseptic 80%
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
CGMP Deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Torco Racing Fuels Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine 2.5% Cream
cGMP Deviations
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Kill 'Dat Sanitizing Products Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
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