June 2024 FDA Recall Sinufrin Quick Relief Decongestant by Neilmed Pharmaceuticals Inc
D-0569-2024 - Sub-potent Drug
This Class III drug recall was voluntarily initiated by Neilmed Pharmaceuticals Inc on June 24, 2024 for the product Sinufrin Quick Relief Decongestant. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0569-2024
Sub-potent Drug
06-24-2024
07-03-2024
20,370 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Neilmed Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: SD134; Exp: 10/31/2026
