Green Pharmaceuticals Inc has issued a voluntary nationwide recall of SnoreStop NasoSpray lot 2373/21222 due to the presence of microbial contamination. The consumer-level recall affects products packaged in 0.3 FL OZ (9ml) bottles. The FDA testing discovered the presence of microbial contamination known as Providencia rettgeri.
Risk Statement
While the microorganism is rarely associated with human illness, immunocompromised patients that use the affected products may be at risk of infection.
The use of these products can result in life-threatening events such as septicemia, endocarditis, and meningitis. For non-immunocompromised patients, using the affected products can result in the risk of infections that may not be severe and can respond to treatment.
To date, Green Pharmaceuticals has not received any reports of adverse events that may be associated with the use of these products.
Indications
SnoreStop NasoSpray is used to help reduce snoring by providing temporary relief of nasal congestion due to enlarged turbinates. The product is packaged in one single-unit plastic bottle with a nasal pump. It is available over the counter without a prescription.
The recall affects only lot 2373/21222 of SnoreStop NasoSpray, and no other lots or products from Green Pharmaceuticals Inc are affected. You can identify the affected product through its clear transparent plastic box containing the name SnoreStop NasoSpray.
Green Pharmaceuticals Inc is sending notifications to retailers and consumers by email and is arranging for the return of the product. Consumers should immediately stop using the recalled product and contact their healthcare provider if they have experienced any problems that may be related to using it.
Green Pharmaceuticals is also notifying its distributors and customers by email, telephone and fax and is arranging for the return of all affected products.
Customers with questions can call Green Pharmaceutical at 805-388- 0600 Monday through Friday, 8 AM to 5 PM Pacific Standard Time or e-mail address ([email protected]).
For any adverse reactions or quality issues, consumers should contact the FDA’s MedWatch Adverse Event Reporting program online, by phone, or by fax:
Online: www.fda.gov/medwatch/report.htm
Phone: 1-800-FDA-1088
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
