Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Cholesterol Medication Recalls
Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.
161 recalls in this category, newest first.
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.
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
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10-10mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
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