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
Reported: October 26, 2022 Initiated: September 30, 2022 #D-0010-2023
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
Reason for Recall
Out of specification for related substances (impurities).
Details
- Recalling Firm
- Ingenus Pharmaceuticals Llc
- Units Affected
- 6176 bottles
- Distribution
- Nationwide within the United States
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ingenus Pharmaceuticals Llc. Units affected: 6176 bottles.
Why was this product recalled? ▼
Out of specification for related substances (impurities).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 26, 2022. Severity: Moderate. Recall number: D-0010-2023.
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