Drug product
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01
D-0528-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 injector
- Official record key
drug-enforcement:D-0528-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 0FM544
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations