Drug product
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
D-1838-2019
Product summary
- Firm
- Ucb, Inc
- Event
- Event 83368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2088 bottles
- Official record key
drug-enforcement:D-1838-2019
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot: 908946 Exp. 02/2022
Distribution pattern: TN
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications