Cholesterol Medication Recalls

Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.

161 recalls in this category, newest first.

Class III · Low risk Terminated Jul 11, 2017

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC…

Reason Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

Dr. Reddy's Laboratories, Inc. NDC 55111-229-90 D-1038-2017

Class II · Moderate risk Terminated Mar 21, 2017

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan…

Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-208-20 D-0622-2017

Class II · Moderate risk Terminated Mar 20, 2017

Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC…

Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Mylan Pharmaceuticals Inc. NDC 0378-3953-09 D-0621-2017

Class II · Moderate risk Terminated Mar 20, 2017

Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC…

Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Mylan Pharmaceuticals Inc. NDC 0378-3952-09 D-0620-2017

Class II · Moderate risk Terminated Mar 20, 2017

Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC…

Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Mylan Pharmaceuticals Inc. NDC 0378-3951-09 D-0619-2017

Class II · Moderate risk Terminated Mar 20, 2017

Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09)…

Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Mylan Pharmaceuticals Inc. NDC 0378-3950-77 D-0618-2017

Class II · Moderate risk Terminated Jul 7, 2016

Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009

Reason CGMP Deviations

Safecor Health, LLC D-0901-2017

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0823-2016

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0822-2016

Class III · Low risk Terminated Mar 24, 2016

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles…

Reason Subpotent Drug

Biocon Inc NDC 24658-0300-90 D-0817-2016

Class III · Low risk Terminated Mar 17, 2016

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date

Impax Laboratories, Inc. NDC 0115-0533-02 D-0821-2016

Class III · Low risk Terminated Mar 17, 2016

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date

Impax Laboratories, Inc. NDC 0115-0522-02 D-0820-2016

Class III · Low risk Terminated Jan 27, 2016

Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…

Reason Failed Impurities/Degradation Specifications

Golden State Medical Supply Inc. NDC 60429-326-77 D-0770-2016

Class III · Low risk Terminated Jan 27, 2016

Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…

Reason Failed Impurities/Degradation Specifications

Golden State Medical Supply Inc. NDC 60429-325-77 D-0769-2016

Class III · Low risk Terminated Jan 27, 2016

Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…

Reason Failed Impurities/Degradation Specifications

Golden State Medical Supply Inc. NDC 60429-324-77 D-0768-2016

Class III · Low risk Terminated Jan 27, 2016

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…

Reason Failed Impurities/Degradation Specifications

Golden State Medical Supply Inc. NDC 60429-323-77 D-0767-2016

Class II · Moderate risk Terminated Sep 4, 2015

Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC…

Reason Failed Dissolution Specifications: Failed 24 month dissolution testing.

Valeant Pharmaceuticals North America LLC D-0163-2016

Class II · Moderate risk Terminated Aug 14, 2015

Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only…

Reason Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.

Merck Sharp & Dohme, Wilson Facility NDC 66582-0312-82 D-0007-2016