SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-coun
Summary
The FDA issued a Class I for SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg a by Ascent Consumer Products Inc.. Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus.
Details
Source
Drug Recall
External ID
D-0301-2025
Action Date
2025-04-02
Status
Ongoing
Category
drug
Product Description
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
Lot/Code Info: Lot# 024122661Al, Exp Date 12/2027
Quantity Affected: unknown
Reason for Recall
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-28
Company
Melville, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ascent Consumer Products Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascent Consumer Products Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascent Consumer Products Inc. have FDA actions?
Ascent Consumer Products Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0301-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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