Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.
161 recalls in this category, newest first.
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.
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Failed Dissolution Specifications
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Presence of foreign substance: metallic razor blade was found in one bottle.
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Microbial Contamination of Non-Sterile Products
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
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