Drug product
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
D-0386-2015
Product summary
- Event
- Event 70339
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3263 bottles
- Official record key
drug-enforcement:D-0386-2015
Official wording
Reason: Failed Dissolution Specifications: 6 month time point.
Code information: Lot #: JKN0249A Exp 02/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications