Insight Pharmaceuticals LLC has announced a voluntary recall(www.fda.gov) of one lot of its Nostrilla Nasal Decongestant nasal spray because the product may be contaminated with the respiratory pathogen Burkholderia cepacia. Patients who are immunocompromised and those who have underlying pulmonary conditions -- especially cystic fibrosis -- have an increased risk for serious infection if exposed to B. cepacia.
To date, no illnesses associated with the nasal spray have been reported. The possibility of B. cepacia infection in healthy individuals is remote.
The affected lot, No 11G075, includes more than 34,000 bottles of product and was distributed to retail outlets and pharmacies nationwide. The bottles are marked with the Universal Product Code 6373673005 and bear an expiration date of 05/2014.
Consumers who have purchased Nostrilla may contact the company at (877) 546-9059, Monday through Friday from 9 a.m.-5 p.m. ET, to return the product. Consumers and health care professionals are encouraged to report adverse reactions(www.accessdata.fda.gov) associated with use of this product to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.
According to the Insight Pharmaceuticals website, health-related inquiries may be directed to the company at (800) 367-5423.