One lot of Zicam Extreme Congestion Relief nasal gel has been recalled by its manufacturer after routine testing revealed Burkholderia cepacia bacteria in a sample, the U.S. Food and Drug Administration reported.
The company, Matrixx Initiatives, said the affected lot had been distributed nationwide. The lot consists of 0.5-ounce spray bottles containing a nondrip liquid, in cartons labeled with NDC number 62750-005-10, lot number 2J23, with an expiration date of September 2015.
Read this story on www.medpagetoday.com.
According to the firm's recall notice, the organism poses little risk to healthy individuals. But introducing it into nasal passages could lead to colonization and, in people with compromised immune systems or chronic lung conditions such as cystic fibrosis, to potentially serious infections.
Matrixx also indicated that B. cepacia resists many antibiotics and can be difficult to eradicate in sensitive populations.
No reports of illness were conveyed to the company. It also noted that the bacteria were detected only in a single sample. Other samples from the same lot were negative for contamination.
The active ingredient in the product is oxymetazoline HCl. Matrixx markets the gel for relief of nasal congestion and sinus pressure.