Drug product
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
D-1584-2019
Product summary
- Event
- Event 83471
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,360 bottles
- Official record key
drug-enforcement:D-1584-2019
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) G702705 and b) G702706, Exp. 3/31/2020
Distribution pattern: Nationwide within the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification