Insight Pharmaceuticals, LLC of Langhorne, Pa., is recalling one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.
Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis). However, the possibility of infection is remote in healthy individuals.
Nostrilla Nasal Decongestant, lot 11G075, UPC Code 6373673005, was distributed nationwide through normal 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. No illnesses have been reported to date in connection with this problem.
The recall was initiated following internal investigations which determined the potential presence of a microbial contaminant that exceeds the product specifications and may consequently result in a subpar product. This contaminant has been found sporadically throughout only the respective manufacturing lot, 11G075.
Consumers who have purchased "Nostrilla Decongestant, lot 11G075" are urged to return the product and contact the company at 1-877-546-9059 Monday through Friday from 9 a.m.-5 p.m. EST time zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm22. Mail to address on the pre-addressed form.
* Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
"It is our commitment to our customers to provide them with products they can rely on as safe and effective for their FDA-approved uses," says Gary R. Downing, CEO of Insight Pharmaceuticals, LLC. "Through our standard testing procedures and protocols, we discovered the potential presence of a bacterial contaminant in one lot of Nostrilla, and reported it to the FDA. Consumer safety is our No. 1 priority, and we'll take all necessary action to ensure Nostrilla, as well as all of our products, comply with FDA regulations and requirements."