February 28, 2019
Lupin Pharmaceuticals Inc. is recalling 44,640 bottles of lovastatin tablets, 40 mg, because a substance used to manufacture the drug tested out of specification for impurities, according to the February 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 60-count bottles (NDC 68180-469-07) from lot G702755 (Exp. 3/20) and 100-count bottles (NDC 68180-469-01) from lot G702756 (Exp. 3/20). The affected bottles were distributed throughout the United States and in Puerto Rico.
Lupin Pharmaceuticals voluntarily initiated the recall February 13, 2019. The FDA designated the recall Class III on February 20, 2019. Under the recall classification, use of the affected tablets is not likely to cause harm.
Lovastatin is a prescription statin used to treat high cholesterol and coronary heart disease.