SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12
Summary
The FDA issued a Class III for SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Dec by Neilmed Pharmaceuticals Inc. Reason: Sub-potent Drug.
Details
Source
Drug Recall
External ID
D-0569-2024
Action Date
2024-07-03
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: SD134; Exp: 10/31/2026
Quantity Affected: 20,370 bottles
Reason for Recall
Sub-potent Drug
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-24
Company
Santa Rosa, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Neilmed Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Neilmed Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Neilmed Pharmaceuticals Inc have FDA actions?
Neilmed Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0569-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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