Green Pharmaceuticals has voluntarily recalled 1 lot of SnoreStop NasoSpray to the consumer level due to microbial contamination identified by the Food and Drug Administration (FDA) as Providencia rettgeri, a gram-negative bacterium.
SnoreStop NasoSpray is a homeopathic medicine used to temporarily stop or reduce symptoms of nonapneic snoring. The recalled lot of SnoreStop NasoSpray is 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 affected product was distributed nationwide and is packaged in 0.3 fluid ounce (9mL) bottles.
While the risk of infectious complications is expected to be less severe in healthy individuals, use of the recalled product by immunocompromised patients could potentially result in severe or life-threatening adverse events including bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. To date, the Company has not received any reports of adverse events related to this recall.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Green Pharmaceuticals Inc issues voluntary nationwide recall of SnoreStop NasoSpray due to microbial contamination. News release. Green Pharmaceuticals Inc. June 9, 2022. Accessed June 13, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-pharmaceuticals-inc-issues-voluntary-nationwide-recall-snorestop-nasospray-due-microbial