Why it was recalled
Sub-potent 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 numbers, UPCs & expiration codes
Lot: SD134; Exp: 10/31/2026
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0569-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 24, 2024
- FDA report date
- Jul 3, 2024
- Quantity
- 20,370 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Neilmed Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0569-2024, exactly as published.
Show all FDA fields
- City
- Santa Rosa
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94853
- Address
- 601 Aviation Blvd
- Code information
- Lot: SD134; Exp: 10/31/2026
- Postal code
- 95403-1025
- Report date
- Jul 3, 2024
- Product type
- Drugs
- Recall number
- D-0569-2024
- Classification
- Class III
- Recalling firm
- Neilmed Pharmaceuticals Inc
- Product quantity
- 20,370 bottles
- Reason for recall
- Sub-potent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 24, 2024
- Initial firm notification
- Center classification date
- Jun 28, 2024