FDA-Drug2025-04-02Class I

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

Ascent Consumer Products Inc.
Hazard

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

Sold states
Nationwide in the US.
Affected count
4,176 cartons
Manufactured in
105 Baylis Rd, N/A, Melville, NY, United States
Products
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2025

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