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.
Reason for recall: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Recall initiated: 20190219
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated