COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Microbial contamination of the product with Staphylococcus aureus (S. aureus)
- Company Name:
- Ascent Consumer Products Inc.
- Brand Name:
-
Brand Name(s)
- Product Description:
-
Product Description
Soft Tip Squeeze Bottle Nasal Wash System
Company Announcement
FOR IMMEDIATE RELEASE: 02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus).
Risk Statement:
Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus, can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation. Resulting secondary infections may occur, such as endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses or meningitis, and bacterial sinusitis which may lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis. These infections are serious and potentially life-threatening. To date, no adverse events have been reported to Ascent Consumer Products, Inc. related to this recall.
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is used as a nasal wash of the nasal passages to help temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies. The only affected product lot includes the following:
Product Name |
Lot Number |
Expiration Date |
|---|---|---|
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System |
024122661A1 |
12-31-2027 |
The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is packaged in a carton, containing the squeeze bottle and 30 Saline Packets. The lot number and expiration date can be identified on the side of the carton or on the back of the Saline Packets within the carton. The affected lot was distributed in January 2025 nationwide through retail and online outlets.
Ascent Consumer Products Inc. is notifying its distributors and customers by electronic mail. Distributors and retailers in possession of the affected lot should immediately cease distribution and remove the recalled SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System lot from inventory. Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it.
Consumers with questions regarding this recall can contact Ascent Consumer Products Inc. by email at cs@ascentconsumerproducts.com Monday-Friday from 9am-5pm ET. Consumers should contact their physician or healthcare provider if they experience any problems related to the use of this product.
Reporting Adverse Reactions
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program:
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
