FDA MedWatch - SnoreStop NasoSpray by Green Pharmaceuticals:
U.S. Food and Drug Administration sent this bulletin at 06/10/2022 08:49 AM EDT
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: SnoreStop NasoSpray by Green Pharmaceuticals: Recall - Due to Microbial Contamination
AUDIENCE: Consumer, Health Professional
ISSUE: Green Pharmaceuticals is recalling lot 2373/21222 of SnoreStop NasoSpray because FDA testing found product to contain microbial contamination identified as Providencia rettgeri.
This microorganism is rarely associated with human illness; however, in immunocompromised patients, the use of the recalled product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the use of the recalled product may result in infectious complications that are expected to be less severe and more readily responsive to treatment.
To date, Green Pharmaceuticals has not received any reports of adverse events related to this recalled lot.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is used as a nasal spray to temporarily help stop or reduce symptoms of non-apneic snoring.
RECOMMENDATIONS:
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Consumers and retailers that have product which is being recalled should stop using and return to place of purchase. Green Pharmaceuticals is arranging for return and replacement of all recalled products.
Consumers with questions regarding this recall can contact the company.
Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
