Sinufrin Quick Relief Decongestant Spray
FDA Recall NDC 13709-325

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Sinufrin Quick Relief Decongestant (NDC 13709-325). A significant event, classified as Class III, was initiated on Jun 24, 2024 by Neilmed Pharmaceuticals Inc.. The reported reason for this action was: "Sub-potent Drug"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0569-2024ONGOING

June 2024 Class III Recall: Sub-potent Drug

Recall Number
D-0569-2024
Class III Ongoing
Reason for Recall
Sub-potent Drug
Initiated
Jun 24, 2024
Reported
Jul 03, 2024
Quantity
20,370 bottles

Recall Profile & Regulatory Data

Event ID
94853
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Neilmed Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
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.
Batch or Lot Expiration Information
Lot# Lot: SD134; Exp: 10/31/2026
Affected Packages Involved in this Recall
13709-325-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.