Why it was recalled
Out of specification for related substances (impurities).
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0010-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Sep 30, 2022
- FDA report date
- Oct 26, 2022
- Quantity
- 6176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ingenus Pharmaceuticals Llc
Original FDA data
Every field from FDA enforcement report D-0010-2023, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Completed
- Country
- United States
- Event ID
- 90934
- Address
- 4190 Millenia Blvd
- Code information
- Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
- Postal code
- 32839-6408
- Report date
- Oct 26, 2022
- Product type
- Drugs
- Recall number
- D-0010-2023
- Classification
- Class II
- Recalling firm
- Ingenus Pharmaceuticals Llc
- Product quantity
- 6176 bottles
- Reason for recall
- Out of specification for related substances (impurities).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 30, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2022