Drug Enforcement D-0300-2025

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

Status

Ongoing

Classification

Class I

Report Date

April 2, 2025

Termination Date

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Product Information

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
Product quantity
unknown
Reason for recall
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the US.

Location & Firm

Recalling firm
Ascent Consumer Products Inc.
Address
105 Baylis Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0300-2025
Event ID
96290
Recall initiation date
January 28, 2025
Center classification date
March 25, 2025
Code info
Lot# 024122661Al, Exp Date 12/2027
More code info
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