Drug product
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
D-1325-2022
Product summary
- Event
- Event 90553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 cartons
- Official record key
drug-enforcement:D-1325-2022
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