December 19, 2012
Matrixx Initiatives Recalls Zicam® Extreme Congestion Relief Due to Contamination with Burkholderia Cepacia
The Missouri Department of Health and Senior Services received information regarding the recall of Zicam® Extreme Congestion Relief nasal gel due to the findings of a bacteria called Burkholderia cepacia.
Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.
The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing NDC number 62750-005-10. The affected Zicam® Extreme Congestion Relief lot is 2J23, Expiration 09/15. The product was distributed to retailers nationwide throughout the United States.
The full recall can be found at http://www.fda.gov/Safety/Recalls/ucm332787.htm.