Drug 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.
D-0513-2019
Product summary
- Event
- Event 82126
- Status
- Terminated
- Classification
- Class III
- Quantity
- 44,640 bottles
- Official record key
drug-enforcement:D-0513-2019
Official wording
Reason: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Code information: Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification