Recalls / Class III
Class IIID-0569-2024
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.
- Brand name
- Sinufrin Quick Relief Decongestant
- Generic name
- Sinufrin
- Active ingredient
- Oxymetazoline
- Route
- Nasal
- NDC
- 13709-325
- FDA application
- M012
- Affected lot / code info
- Lot: SD134; Exp: 10/31/2026
Why it was recalled
Sub-potent Drug
Recalling firm
- Firm
- Neilmed Pharmaceuticals Inc
- Manufacturer
- Neilmed pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 601 Aviation Blvd, Santa Rosa, California 95403-1025
Distribution
- Quantity
- 20,370 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-06-24
- FDA classified
- 2024-06-28
- Posted by FDA
- 2024-07-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0569-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.