The FDA is warning consumers not to use SnoreStop Nasal Spray. The product, distributed by Green Pharmaceuticals Inc. of Camarillo, CA, may be microbially contaminated and the company will not issue a recall. Using a nasal spray that is microbially contaminated can cause life-threatening infections in immune-compromised individuals, according to the U.S. Food and Drug Administration (FDA).
This product has not received FDA approval as is being marketed to consumers ages 5 and older with unproven claims that it opens air passages and relieves congestion, the agency stated in its consumer warning.
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Green Pharmaceuticals Lack of Quality Control
During an April 2024 inspection, FDA investigators found evidence that some products from a microbially contaminated lot had been repackaged and sold as single units and in kits.
After the FDA inspected the facility again on August 8, 2024, and the company destroyed the remaining products from the contaminated lot and stopped selling nasal sprays on their website. Out of concern that some consumers may have purchased contaminated nasal sprays, the FDA requested on August 13, 2024, that Green Pharmaceuticals issue a recall. When the company took no action, the FDA again recommended a recall on September 12, 2024. Still, no action has been taken.
This isn’t the first time Green Pharmaceuticals has had an issue with microbial contamination.
In June 2022, the company issued a recall for SnoreStop NasoSpray after products tested by the FDA were found to be microbially contaminated. After the recall, the product was renamed SnoreStop Nasal Spray. In December 2024, the FDA issued a warning letter to Green Pharmaceuticals for its lack of quality control and for selling unapproved drugs.
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