SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant…

Date

July 3, 2024

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Ongoing

Filed by

Neilmed Pharmaceuticals Inc

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

Sub-potent Drug

Distribution pattern

Nationwide in the US

Quantity

20,370 bottles

Codes and lots

Lot: SD134; Exp: 10/31/2026

Recall started

June 24, 2024

Recall number

D-0569-2024

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0569-2024. The agency record governs; check it and the company before acting.