Nasal wash products called SinuCleanse that were distributed last month through retail and online outlets have been recalled due to microbial contamination with Staphylococcus aureus (S. aureus), according to the U.S. Food and Drug Administration.
According to the U.S. Centers for Disease Control and Prevention, this bacterium is also commonly called staph. While around 30% of people carry the germ in their nose and it often does not cause harm, it can sometimes cause dangerous infections.
Ascent Consumer Products Inc., the manufacturer, announced the recall Tuesday. Only one lot of the product was affected. On the box, the recalled products will have lot number 024122661A1 and a 12-31-2027 expiration date.
Described as a “Soft Tip Squeeze Bottle Nasal Wash System,” the product is used to wash the nasal passages and temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies. It includes the squeeze bottle and 30 saline packets (which also have the lot number and expiration date), with the active ingredients listed as sodium bicarbonate and sodium chloride.
A test result confirmed that the recalled lot confirmed that it had been contaminated with S. aureus. Use of product contaminated with this pathogen “can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation,” said the FDA.
Staph might also lead to secondary infections. These include endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses or meningitis, and bacterial sinusitis. Additionally, bacterial meningitis may lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis.
“These infections are serious and potentially life-threatening,” said the FDA.
As of Tuesday, no adverse events related to the Ascent Consumer Products, Inc. recall had been reported, the agency added. It said that the company is notifying distributors and customers via email.
Distributors and retailers are instructed to immediately cease distribution and remove the recalled SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System lot. Likewise, consumers should discontinue use immediately and either return the product to the place where they purchased it or discard it.
Want to get caught up on what's happening in SoCal every weekday afternoon? Click to follow The L.A. Local wherever you get podcasts.
“Consumers with questions regarding this recall can contact Ascent Consumer Products Inc. by email at cs@ascentconsumerproducts.com Monday-Friday from 9 a.m. to 5 p.m. ET,” said the FDA. “Consumers should contact their physician or healthcare provider if they experience any problems related to the use of this product.”
If anyone does have an adverse reaction to the product, the FDA instructs them to contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.
People can also reach the MedWatch Adverse Event Reporting program by calling 1-800-332-1088 to request a reporting form, then completing it an and returning it to the address on the pre-addressed form, or by submit by fax to 1-800-FDA-0178.
Follow KNX News 97.1 FM