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SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium c...

FDA Recall #D-0299-2025 — Class I — January 28, 2025

Recall #D-0299-2025 Date: January 28, 2025 Classification: Class I Status: Ongoing

Product Description

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

Recalling Firm

Ascent Consumer Products Inc. — Melville, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

4,176 cartons

Distribution

Nationwide in the US.

Code Information

Lot# 024122661Al, Exp Date 12/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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