Drug product
CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
D-0452-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 patches
- Official record key
drug-enforcement:D-0452-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 1905666/2
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations