Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations
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
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Rosuvastatin Tablets 40mg
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets 80mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
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