Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
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
Estradiol Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Micronized Bulk
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA
CGMP Deviations
Class II · Moderate risk
Gentell Hydrogel Wound Dressing REGULAR
CGMP Deviations
Class II · Moderate risk
Gentell Hydrogel Ag Saturated Gauze
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class III · Low risk
VirtPrex Prenatal/Postnatal Tablets
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Select Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Extra-Virt Plus DHA Prenatal/Postnatal Softgel
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Advance Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
CGMP Deviations
Class II · Moderate risk
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk
Comfort Shield
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
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