Insight Pharmaceuticals, LLC of Langhorne, Pennsylvania, is recalling one lotâ€”34,092 bottlesâ€”of its Nostrilla Nasal Decongestant nasal spray over concerns that the nasal spray is contaminated with the bacteria, Burkholderia cepaciam, the U.S. Food and Drug Administration (FDA) just announced.
Burkholderia cepaciam may cause serious infection in individuals with a compromised immune system or a chronic lung condition, such as cystic fibrosis. According to the FDA, the potential for infection is fairly remote in healthy individuals.
Nostrilla Nasal Decongestant, lot #11G075, UPC Code 6373673005, was distributed nationwide through normal retail outlets and pharmacies. The product is packaged in a Â½-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 with this defective medical product.
The recall was initiated following internal investigations that revealed the potential presence of a microbial contaminant in excess of product specifications and which may also result in a sub-par product.
The contaminant was found sporadically throughout manufacturing lot, #11G075; therefore, consumers who purchased “Nostrilla Decongestant, lot #11G075″ are urged to return the product and contact Insight Pharmaceuticals, toll-free, at 1.877.546.9059, Monday through Friday, from 9:00 a.m. to 5:00 p.m., Eastern Standard Time (EST).
Consumers are advised to contact their physician or healthcare provider if they have experienced any problems that may be connected to taking or using the defective, recalled Nostrilla Nasal Decongestant nasal spray .
Adverse reactions or quality problems experienced with the use of the recalled Nostrilla Nasal Decongestant nasal spray may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at www.fda.gov/medwatch/report.htm; by regular mail by using postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mailing to the address on the pre-addressed form; or by fax to 1.800.FDA.0178.