Class II · Moderate risk
Rufinamide Tablets 200mg
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
Frovatriptan Succinate Tablets 2.5mg
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 200mg
CGMP Deviations
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets 50mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets 200 mg
CGMP Deviations
Class II · Moderate risk
Solifenacin Succinate Tablets 10MG
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
In Your Face Mineral Tint SPF 31
cGMP deviations
Class II · Moderate risk
GreenScreen
cGMP deviations
Class II · Moderate risk
Erin's Faces
cGMP deviations
Class II · Moderate risk
B Natural Organics
cGMP deviations
Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Class II · Moderate risk
Bimatoprost NDC# 82187-1001-1 Container description: The…
CGMP Deviations
Class II · Moderate risk
Inflectra (infliximab-dyyb)
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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