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.

FDA recall notice · announced February 27, 2019 · Lupin Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide in the USA and Puerto Rico.
Lot/code information: Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
Quantity: 44,640 bottles
Status: Terminated
Products in this recall event:
- 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; (D-0513-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.