Zicam Extreme Congestion Relief Nasal Gel
December 19, 2012
Matrixx Initiatives issued a voluntary recall of one lot of its Zicam Extreme Congestion Relief nasal gel after the product was determined to be contaminated by Burkholderia cepacia. The contamination was discovered during routine testing by the manufacturer and was determined to be isolated to one lot of manufactured product. The affected products were distributed throughout the United States.
Contaminated Product Information:
Zicam Extreme Congestion Relief Nasal Gel, 0.5 oz. spray bottle (NDC 62750-005-10): lot number: 2J23 (expiry September, 2015)
For healthy individuals, Burkholderia cepacia poses very little risk for infection. However, this organism could lead to nasal colonization and upper respiratory infections in immunocompromised patients or patients with chronic lung diseases. Burkholderia cepacia has demonstrated resistance to many antibiotics and poses a challenge to treatment in those patients with an active infection.
Immediately stop using and quarantine any affected product. Return the affected product by calling Matrixx at 1-877-942-2626 Monday through Friday, from 8AM to 8PM or on Saturday from 9AM to 1PM Central Time. Report any adverse events to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
December 19, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.