SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 m...
FDA Recall #D-0300-2025 — Class I — January 28, 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
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
unknown
Distribution
Nationwide in the US.
Code Information
Lot# 024122661Al, Exp Date 12/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated