Drug product
ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
D-0525-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 122 inhalers
- Official record key
drug-enforcement:D-0525-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: T023471
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations