← FDA ENFORCEMENT
D-0300-2025Class I

Ascent Consumer Products Inc.

Recalling firm
Ascent Consumer Products Inc.
Product type
Drug
Status
Ongoing
Report date
2025-04-02
Distribution
Nationwide in the US.
Firm state
NY
Product quantity
unknown
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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

Code / lot info

Lot# 024122661Al, Exp Date 12/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.