FDA Issues Warning Letter for Unapproved, Contaminated Nasal Spray
An over-the-counter homeopathic anti-snoring nasal spray manufactured by Green Pharmaceuticals contained “gross microbial contamination,” including large numbers of the aerobic bacteria Providencia rettgeri, as well as yeast and mold, the FDA said in a warning letter to the company.
In a post-inspection briefing with the FDA, company officials said they received the product from a contract manufacturer but did not test it before repackaging it into the intranasal dispenser.
The company received the warning letter about its SnoreStop NasoSpray after the FDA found the contaminants during batch sample testing.
Additionally, SnoreStop appears to be marketed as a drug but has not been approved as one, the agency said.