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.

Recall Number: D-0513-2019

Firm: Lupin Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20190227

Initiation Date: 20190213

Termination Date: 20201006

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

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.