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Class I · Most seriousActive recall

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot# 024122661Al, Exp Date 12/2027
Where it was soldNationwide in the US.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAscent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
Show the full FDA record
Full product labelSinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
Recalling firmAscent Consumer Products Inc.
DistributionNationwide in the US.
Quantityunknown
Recall initiated2025-01-28
Report date2025-04-02
Recall completed—
Recall numberD-0300-2025
ClassificationClass I
FDA statusOngoing
Origin on fileMelville NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.