Matrixx Initiatives voluntarily recalled one lot of Zicam Extreme Congestion Relief nasal gel after the manufacturer found 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.
The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 ounce 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 throughout the United States.
See the Recall