United States
Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. To date, Green Pharmaceuticals Inc has not received any reports of adverse events related to this recalled lot.
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.
The product is used as a nasal spray to temporarily help stop or reduce symptoms of non-apneic snoring and is packaged in one single unit plastic bottle with a nasal pump as a delivery system. The affected SnoreStop NasoSpray lot includes the following: 2372/21222 (2373 is printed on a sticker placed on the bottom of the bottle and 21222 is on a sticker placed on the outer packaging).
The product can be identified by a clear transparent plastic box with the name SnoreStop NasoSpray. The product was distributed nationwide in health food stores and online. Green Pharmaceuticals Inc is notifying its retailers and customers by email and is arranging for return and replacement of all recalled products. Consumers and retailers that have product which is being recalled should stop using and return to place of purchase.
Consumers with questions regarding this recall can contact Green Pharmaceuticals Inc by phone at 805-388- 0600, Monday through Friday, 8 AM to 5 PM Pacific Standard Time. 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.
Company name: Green Pharmaceuticals Inc
Brand name: SnoreStop
Product recalled: Nasal spray
Reason of the recall: Due to microbial contamination identified as Providencia rettgeri.
FDA Recall date: June 09, 2022
Source:
www.fda.gov
