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.
Reason for recall: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Recall initiated: 20190213
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated