Recalls / Class II
Class IID-0010-2023
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
- Brand name
- Flunisolide
- Generic name
- Flunisolide
- Active ingredient
- Flunisolide
- Route
- Nasal
- NDC
- 50742-317
- FDA application
- ANDA207802
- Affected lot / code info
- Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Why it was recalled
Out of specification for related substances (impurities).
Recalling firm
- Firm
- Ingenus Pharmaceuticals Llc
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4190 Millenia Blvd, N/A, Orlando, Florida 32839-6408
Distribution
- Quantity
- 6176 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-09-30
- FDA classified
- 2022-10-17
- Posted by FDA
- 2022-10-26
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.