Drug product
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66
D-0591-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 bottles
- Official record key
drug-enforcement:D-0591-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 309750
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations