Recall: D-0513-2019

Class III - Minor Violations

Class IIIClassification

2019-02-13Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

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

Distribution

Nationwide in the USA and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.