Class II · Moderate risk
Rosuvastatin Tablets
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
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Montelukast Sodium Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glycopyrrolate Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP 1 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Doxazosin Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Doxazosin Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Doxazosin Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Doxazosin Tablets USP 1 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules 500 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules 250 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
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