Medicine recalls
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| The United States: Ascent Consumer Products Inc. issues voluntary nationwide recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (lot number: 024122661A1) 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).
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 affected lot was distributed in January 2025 nationwide through retail and online outlets.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascent-consumer-products-inc-issues-voluntary-nationwide-recall-sinucleanse-soft-tip-squeeze-bottle
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Feb 26, 2025
Issued at HKT 15:30
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