Insight Pharmaceuticals, LLC of Langhorne, PA announced a recall of their Nostrilla Nasal Decongestant spray, because it may be tainted with Burkholderia cepacia. The company is recalling one lot, which amounts to 34,092 bottles, from consumers.
B. cepacia is a bacterium that can cause a potentially life threatening infection in immunocompromised individuals or those with a chronic lung condition, such as cystic fibrosis. According the Centers for Disease Control and Prevention (CDC), B. cepacia poses little risk to healthy people.
The products affected by the recall were printed with a lot number of 11G075 and an expiration date of 05/2014. Insight Pharmaceuticals discovered the bacterial contamination during its internal testing procedures and subsequently informed the Food and Drug Administration (FDA). No illnesses have been reported in connection to the products’ contamination.
“As a DEA-licensed and FDA-registered laboratory, EMSL Analytical provides reliable B. cepacia and pathogen testing services to help companies comply with regulations,” states Diane Miskowski, MPH, Business Development Manager at EMSL. “We welcome independent client audits of our lab practices to demonstrate our cGMP compliance.”
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of quality environmental and materials testing services and products to professionals and the general public. The company has an extensive list of accreditations from leading professional organizations as well as state and federal regulatory agencies.