ARS TECHNICA – The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and Drug Administration once again found evidence of dangerous microbial contamination.
In a warning Thursday, the FDA advised consumers to immediately stop using SnoreStop nasal spray—made by Green Pharmaceuticals—because it may contain microbes that, when sprayed directly into nasal cavities, can cause life-threatening infections.
The FDA highlighted the risk to people with compromised immune systems and also children, since SnoreStop is marketed to kids as young as age 5.
According to the regulator, an FDA inspection in April uncovered laboratory test results showing that a batch of SnoreStop contained “significant microbial contamination.”
But, instead of discarding the batch, FDA inspectors found evidence that Green Pharmaceuticals had repackaged some of the contaminated lot and distributed it as single spray bottles or as part of a starter kit.
“There’s been extensive investigation of the effectiveness of homeopathy. There’s no good-quality evidence that homeopathy is effective as a treatment for any health condition.” – National Health Service, UK
In response, Green Pharmaceuticals destroyed the remainder of the tainted lot and stopped selling the nasal spray on its website. (It is still selling its SnoreStop throat spray, chewable tablets, and pet products, which includes a nasal spray.)
But, according to the FDA, it refused to recall products that may contain product from the tainted lot.
The agency said it “reiterated its recall recommendation multiple times” in August and September. But, “To date, the company has not taken action to recall this potentially dangerous product from the market.”
Ars has reached out to Green Pharmaceuticals for comment but has not received a response. This isn’t new territory for the company. In 2022, Green Pharmaceuticals got warnings from the FDA and issued a recall due to microbial contamination in its SnoreStop nasal spray.
In June 2022, the FDA held a conference with the company over findings of bacteria and fungi in the spray. Some of the results suggested high levels of microbial contamination.
