FDA recall D-0569-2024

Neilmed Pharmaceuticals Inc · Class III · drug

Product

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

Reason for recall

Sub-potent Drug

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2024-06-24
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Rosa, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0569-2024