Drug product
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
D-0010-2023
Product summary
- Event
- Event 90934
- Status
- Completed
- Classification
- Class II
- Quantity
- 6176 bottles
- Official record key
drug-enforcement:D-0010-2023
Official wording
Reason: Out of specification for related substances (impurities).
Code information: Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification