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.

Recall Number: D-1584-2019

Firm: American Health Packaging

Classification: Class III

Status: Terminated

Report Date: 20190814

Initiation Date: 20190219

Termination Date: 20200909

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) 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.