Class II · Moderate risk
Optim V
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
Kofal
CGMP Deviations
Class II · Moderate risk
KOFAL Original
CGMP Deviations
Class II · Moderate risk
Kingskin
CGMP Deviations
Class II · Moderate risk
Cura Hongos
CGMP Deviations
Class II · Moderate risk
Cura Hongos
CGMP Deviations
Class II · Moderate risk
Artridon Glucosamine
CGMP Deviations
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Urodel
cGMP deviations
Class II · Moderate risk
Rapidol Arnica Tablets
cGMP deviations
Class II · Moderate risk
Rapidol Arnica Gel
cGMP deviations
Class II · Moderate risk
Kingskin
cGMP deviations
Class II · Moderate risk
DoloEar Earache Drops
cGMP deviations
Class II · Moderate risk
DoloDent Maximum Strength Toothache Drops
cGMP deviations
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
Kapsin Ointment
CGMP Deviations
Class II · Moderate risk
Hemopropin Ointment
CGMP Deviations
Class II · Moderate risk
Bimatoprost powder
CGMP Deviations
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
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