Class II · Moderate risk
All Germall
Lack of Processing Controls
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
All betamethasone diproprionate Products
Lack of Processing Controls
Class II · Moderate risk
All monobenzone Products
Lack of Processing Controls
Class II · Moderate risk
All carbomer Products
Lack of Processing Controls
Class II · Moderate risk
All progesterone Products
Lack of Processing Controls
Class II · Moderate risk
All Peterson Cream Products
Lack of Processing Controls
Class II · Moderate risk
All TRIE Products
Lack of Processing Controls
Class II · Moderate risk
All estriol Products
Lack of Processing Controls
Class II · Moderate risk
All testosterone Products
Lack of Processing Controls
Class II · Moderate risk
All 4-aminopyridine Products
Lack of Processing Controls
Class III · Low risk
Oxygen
CGMP Deviations: Cylinders filled using out of date gauges.
Class II · Moderate risk
Oxygen
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Women
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Salises Facial Moisturizing Acne Treatment Gel
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Antiperspirant Solution
cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
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