American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-3

Recalled August 14, 2019 · FDA recall D-1584-2019 · American Health Packaging

Hazard

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. · FDA Class III

Units

14,360 bottles

Sold at

Nationwide within the USA and Puerto Rico

Description

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Product

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

Manufacturer(s)

American Health Packaging

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →