Drug product
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
D-0433-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1278 bottles
- Official record key
drug-enforcement:D-0433-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: MP0138
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations