PlainRecalls
FDA Drug Critical Class I Ongoing

SinuCleanse 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

Reported: April 2, 2025 Initiated: January 28, 2025 #D-0300-2025

Product Description

SinuCleanse 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

Reason for Recall

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

Details

Units Affected
unknown
Distribution
Nationwide in the US.
Location
Melville, NY

Frequently Asked Questions

What product was recalled?
SinuCleanse 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. Recalled by Ascent Consumer Products Inc.. Units affected: unknown.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Which agency issued this recall?
This recall was issued by the FDA Drug on April 2, 2025. Severity: Critical. Recall number: D-0300-2025.