Class II · Moderate risk
Doxycycline100mg Tablets
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
Acyclovir 400mg Tablet
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class II · Moderate risk
Ondansetron Injection USP 40 mg/20 mL
CGMP Deviations
Class II · Moderate risk
Eptifibatide Injection 75 mg/100 mL
CGMP Deviations
Class II · Moderate risk
Linezolid Injection 600 mg/300 mL Rx Only
CGMP Deviations
Class II · Moderate risk
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
CGMP Deviations
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class II · Moderate risk
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube
CGMP Deviations
Class II · Moderate risk
1% Clotrimazol cream
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 500 mg
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
tabcin NOCHE
CGMP Deviations
Class II · Moderate risk
tabcin ACTIVE M.R. Capsules
CGMP Deviations
Class II · Moderate risk
All Malarone
Lack of Processing Controls
Class II · Moderate risk
All potassium bromide Products
Lack of Processing Controls
Class II · Moderate risk
All baclofen Products
Lack of Processing Controls
Class II · Moderate risk
All diethylstilbestrol Products
Lack of Processing Controls
Class II · Moderate risk
All e2-e3-p4 Products
Lack of Processing Controls
Class II · Moderate risk
All tacrolimus Products
Lack of Processing Controls
Class II · Moderate risk
All Nitro Paste
Lack of Processing Controls
Class II · Moderate risk
All hydroquinone Products
Lack of Processing Controls
Class II · Moderate risk
All clobetasol Products
Lack of Processing Controls
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