FDA recall D-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

Reason for recall

Out of specification for related substances (impurities).

Distribution

Nationwide within the United States

Key facts

Status

Completed

Initiation date

2022-09-30

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2023