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Class III: unlikely to cause harmOngoing

Neilmed Pharmaceuticals SinuFrin Decongestant Recall

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongesta…

Neilmed Pharmaceuticals Inc · Santa Rosa, CA

Risk level
Class III
Reported by FDA
Jul 3, 2024
Recall ID
D-0569-2024
Check your lot numberHow we source this data

Summary

Neilmed Pharmaceuticals recalled SinuFrin Decongestant starting Jun 24, 2024. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0569-2024 on Jul 3, 2024. Reason: Sub-potent Drug. Status: Ongoing.

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
E-Mail
Center classification date
Jun 28, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0569-2024, published Jul 3, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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