INSIGHT PHARMACEUTICALS ISSUE VOLUNTARY NATIONWIDE RECALL DUE TO BACTERIAL CONTAMINATION

RECALL TO CONSUMER LEVEL BECAUSE OF POSSIBLE BURKHOLDERIA CEPACIA

COMMENT

Insight Pharmaceuticals recalled 34,092 bottles of Nostrilla Nasal Decongestant nasal spray because it may contain the bacteria Burkholderia cepacia.  This bacterium, known as a “specified” microorganism, has historically been a periodic contaminant of nasal sprays.  The product is sold as a non-sterile product.

Recall — Firm Press Release 

Insight Pharmaceuticals Issues A Voluntary Nationwide Recall Of “Nostrilla Nasal Decongestant” Due To Bacterial Contamination

FOR IMMEDIATE RELEASE – October 19, 2011 – 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 am-5 pm 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

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 #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.