TOPIC: SnoreStop Nasal Spray by Green Pharmaceuticals: Alert - FDA Warns Consumers Not to Use Due to Potential Contamination
AUDIENCE: Consumer, Health Professional
ISSUE: FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc., Camarillo, Calif., because it may have microbial contamination. SnoreStop Nasal Spray was previously sold on the company’s website and other sites.
The use of microbially contaminated nasal spray can potentially lead to infection, which can be life threatening in certain patient populations, such as immune-compromised individuals.
FDA inspected Green Pharmaceuticals facility in April 2024 and uncovered laboratory test results that reported significant microbial contamination in SnoreStop Nasal Spray lot number 2460. FDA investigators found evidence that some products in this lot had been repackaged and distributed to customers for use as single units and in kits.
Following FDA’s inspection, on Aug. 8, 2024, Green Pharmaceutical destroyed the remaining SnoreStop Nasal Spray from lot 2460 and other products the company had on-hand. Green Pharmaceuticals subsequently stopped selling nasal spray products on their website. However, the agency is concerned that consumers may have purchased contaminated SnoreStop.
Previously, FDA issued a warning letter to Green Pharmaceuticals on Dec. 16, 2022, for distributing unapproved drugs and lack of quality controls over the products they sell. Additionally, the company voluntarily recalled one lot of SnoreStop NasoSpray on June 9, 2022, after FDA testing found the product contained microbial contamination identified as Providencia rettgeri. SnoreStop NasoSpray was renamed as SnoreStop Nasal Spray following this recall.
FDA recommended Green Pharmaceuticals recall their SnoreStop Nasal Spray product on Aug. 13 and Sept. 12, 2024. The agency reiterated its recall recommendation multiple times during this time.
To date, the company has not taken action to recall this potentially dangerous product from the market.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: SnoreStop Nasal Spray is marketed for children beginning at age 5 and adults with unproven claims that it opens air passages and relieves congestion.
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