Drug product
INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES
D-0498-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 534 syringes
- Official record key
drug-enforcement:D-0498-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: KIB0M00
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations