Drug product
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
D-1324-2022
Product summary
- Event
- Event 90553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 box
- Official record key
drug-enforcement:D-1324-2022
Official wording
Reason: CGMP Deviations: products were stored outside the drug label specifications.
Code information: Unavailable
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations