The FDA says it has repeatedly called for a recall of SnoreStop Nasal Spray due to contamination risks, but the manufacturer has not complied to date.

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Summary: The FDA has issued a warning against using SnoreStop Nasal Spray, distributed by Green Pharmaceuticals, due to microbial contamination found in the product. Despite FDA recommendations for a recall on multiple occasions, the manufacturer has not complied. The contamination poses serious infection risks, particularly for immune-compromised individuals. The FDA also uncovered poor quality control practices during inspections and previously issued a warning letter to the company.

Key Takeaways:

1. Microbial contamination identified: The FDA has alerted the public to potential microbial contamination in SnoreStop Nasal Spray, cautioning that its use could lead to infections, particularly in immune-compromised individuals, with the potential for serious health complications.
2. Manufacturer’s noncompliance with recall recommendations: Despite multiple recommendations from the FDA to recall SnoreStop Nasal Spray, the manufacturer, Green Pharmaceuticals, has yet to take action, according to the FDA.
3. Previous regulatory warnings and ongoing quality control issues: The FDA notes it previously issued a warning to Green Pharmaceuticals in 2022 for distributing unapproved drugs and failing to maintain adequate quality controls.

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The US Food and Drug Administration (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.

According to a drug safety warning from the FDA, 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. “This unapproved product is marketed for children beginning at age 5 and adults with unproven claims that it opens air passages and relieves congestion,” reads the warning. 

Calls for a Recall

The FDA notes that it recommended Green Pharmaceuticals recall its SnoreStop Nasal Spray product on Aug 13 and Sept 12. The agency reiterated its recall recommendation multiple times during this time. To date, the company has not taken action to recall this product, according to the FDA.

The FDA says it inspected the Green Pharmaceuticals facility in April and uncovered laboratory test results that reported “significant microbial contamination in SnoreStop Nasal Spray lot number 2460.” FDA adds that its 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 the FDA’s inspection, on Aug 8, Green Pharmaceutical destroyed the remaining SnoreStop Nasal Spray from lot 2460 and other products the company had on hand, according to the FDA. Green Pharmaceuticals subsequently stopped selling nasal spray products on its website. However, the FDA is concerned that consumers may have purchased contaminated SnoreStop.

Previous Warning

Previously, the 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 the FDA testing found the product contained microbial contamination identified as Providencia rettgeri. SnoreStop NasoSpray was renamed SnoreStop Nasal Spray following this recall.

The FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to the FDA’s MedWatch Adverse Event Reporting program: 

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178