Monday, January 07, 2013

Matrixx Initiatives Issues Recall of One Lot of Zicam® Extreme Congestion Relief

 Matrixx Initiatives is voluntarily recalling 1 lot of Zicam® Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility.
Tests on additional samples from the same lot have shown no evidence of the organism.
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. Matrixx has not received any reports of illness.

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.