California-based Green Pharmaceuticals Inc. is recalling the 2372/21222 lot of their SnoreStop NasoSpray bottles. The US Food and Drug Administration (FDA) found the 0.3 FL OZ (9 mL) nasal spray bottles to be contaminated with the bacteria, Providencia rettgeri. In light of the recall, the company is notifying its consumers via email and facilitating a return or a replacement of the affected lot. However, to date there have been no reports of adverse events related to this lot.
Commonly found in water and soil, P. rettgeri is an opportunistic pathogen that has been found in urinary tract infections in hospitalized and elderly patients. Although seldom associated with human disease, it can lead to severe or life-threatening adverse events — such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection — in immunocompromised individuals. In regular individuals it can sometimes lead to infectious complications but can be easily remedied with treatment.
Previous and emerging research on this bacterium has associated it with intrinsic multi-drug resistance and nosocomial infections (also referred to as hospital-acquired infections).
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The SnoreStop NasoSpray
Green Pharmaceuticals Inc. is known for its brand of anti-snoring over-the-counter products. They make tablets and nasal sprays for mouth, nose and throat snorers. Their suite also includes anti-snoring tablets for pets.
The NasoSpray was developed to reduce non-apneic snoring. It works by opening the airway in the nose for easier breathing. The red-and-black bottle is supplied with a yellow pump and spray delivery system and comes in a clear plastic box. It was distributed nationwide online and in health food stores.
Consumers who have purchased this lot (2372/21222) of SnoreStop should stop using the product immediately and arrange for a refund or a replacement.
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