FDA recall D-0299-2025

Ascent Consumer Products Inc. · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide in the US.

Key facts

Status: Ongoing
Initiation date: 2025-01-28
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Melville, NY, United States

Primary source

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