Class III · Low risk
Pravastatin Sodium Tablets
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
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
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Atorvastatin Calcium 80 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 40 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 20 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 10 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fenoglide (fenofibrate)
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Free recall alerts
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