Drug recall D-0513-2019
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.
Lots and codes
Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 44,640 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 13, 2019
- Terminated
- October 6, 2020
Related products
- Lovastatin – drug information
- NDC 68180-468 Lovastatin · Lovastatin 20 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-469 Lovastatin · Lovastatin 40 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-467 Lovastatin · Lovastatin 10 mg/1 · Lupin Pharmaceuticals, Inc.