Lupin Pharmaceuticals Inc. recalls Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx

Recalled February 27, 2019 · FDA recall D-0513-2019 · Lupin Pharmaceuticals

Hazard

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

Units

44,640 bottles

Sold at

Nationwide in 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) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.

Manufacturer(s)

Lupin Pharmaceuticals Inc.

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