SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief ...

FDA Recall #D-0569-2024 — Class III — June 24, 2024

Recall #D-0569-2024 Date: June 24, 2024 Classification: Class III Status: Ongoing

Product Description

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

Recalling Firm

Neilmed Pharmaceuticals Inc — Santa Rosa, CA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

20,370 bottles

Distribution

Nationwide in the US

Code Information

Lot: SD134; Exp: 10/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated