Class II · Moderate risk
rOPINIRole Tablets USP 5 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
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
rOPINIRole Tablets USP 4 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 3 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 2 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 1 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.5 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.25 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP 20 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 801 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Vigabatrin for Oral Solution
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Succinylcholine Chloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 80 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 40 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 20 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 5 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
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