August 15, 2019
American Health Packaging is recalling 100- and 1000-count bottles of 40-mg lovastatin tablets. According to the August 14, 2019, US Food and Drug Administration (FDA) Enforcement Report, a substance in the drug tested out of specification for impurities.
The recall affects lovastatin tablets, 40 mg, packaged in 100-count bottles (NDC 68001-316-00) from lot G702705 and 1000-count bottles (NDC 68001-316-08) from lot G702706. Both lots were manufactured by Lupin Limited for BluePoint Laboratories, have an expiration date of March 31, 2020, and were distributed within the United States and in Puerto Rico.
American Health Packaging voluntarily initiated the recall February 19, 2019, according to the FDA Enforcement Report. The FDA designated the recall Class III on August 2, 2019. Under the recall classification, use of the affected tablets is not likely to cause harm.
Lovastatin is a prescription statin used to treat elevated cholesterol and triglyceride levels.