CAMARILLO, Calif. - Green Pharmaceuticals, Inc. is voluntarily recalling the SnoreStop NasoSpray after the U.S. Food and Drug Administration found that the spray contained microbial contamination identified as Providencia rettgeri.
The affected products are packaged in 0.3 FL OZ (9ml) bottles with the lot number 2373/21222 (2373 is printed on a sticker placed on the bottom of the bottle and 21222 is on a sticker placed on the outer packaging).
According to the FDA, the microorganism is rarely associated with making people sick; however, for those who are immunocompromised, the product in question could result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection.
The agency said for those non-immunocompromised, the product could cause less severe infectious complications that could be easily treated.
Green Pharmaceuticals, Inc. said it has not received any reports of adverse events related to this recalled product.
The nasal spray is used to stop and reduce symptoms of non-apneic snoring.
The company is notifying retailers and customers to arrange replacements of the recalled products.
This story was reported from Los Angeles.