Matrixx Initiatives is voluntarily recalling one lot of Zicam Extreme Congestion Relief nasal gel due to contamination with Burkholderia cepacia, the FDA announced in a press release.
Although the bacteria pose little medical risk to healthy individuals, B. cepacia in a nasal spray has the potential to 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, according to the agency.
The affected lot is 2J23, is labeled with the expiration date 09/15 and bears the NDC number 62750-005-10. Zicam Extreme Congestion Relief is a nondrip liquid nasal gel and is packaged in a 0.5 oz. spray bottle. The product has been distributed to retailers nationwide throughout the United States.
So far, there have been no reports of related illness. ests on additional samples from the same lot have shown no evidence of B. cepacia contamination.
The FDA is urging healthcare providers to report any adverse reactions believed to be related to the nasal decongestant to the MedWatch Adverse Event Reporting program.