Recalls

35,000 lots of contaminated nasal spray recalled

Nearly 35,000 bottles of Nostrilla Nasal Decongestant nasal spray, manufactured by Insight Pharmaceuticals, LLC, are being recalled because the nasal spray may contain bacteria that can cause serious infection.

The contaminant was identified as Burkholderia cepacia, a bacteria that can cause serious infection in individuals with a compromised immune system or chronic lung conditions such as cystic fibrosis. Healthy individuals are unlikely to become sick from the bacteria.

The recall includes lot # 11G075, UPC Code 6373673005 of Nostrilla Nasal Decongestant, which was distributed nationwide through retail outlets and pharmacies. The product comes in a 1/2-ounce, plastic bottle marked with lot #11G075 on the label and with an expiration date of 05/2014 stamped on the side. To date, no illnesses have been reported in connection to this problem.

The recall was initiated following internal investigations which found the potential for the presence of a microbial contaminant that exceeds the product specifications and may consequently result in a sub-par product. The contaminant has been found sporadically throughout the recalled lot.

Consumers who have purchased the recalled nasal spray are urged to return the product and contact the company at 1-877-546-9059 Monday through Friday from 9 a.m. until 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have any problems that may be related to the product.

Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA