Birth Trauma / Medical Malpractice

The maker of Zicam Extreme Congestion Relief, an over-the-counter nasal gel, is voluntarily recalling one lot of the treatment because one sample of it at a factory was found to have a contaminant.

http://www.fda.gov/Safety/Recalls/ucm332787.htm

In a press release issued by the Food and Drug Administration, Matrixx Initiatives said it was doing the recall 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,” the press release said. “Tests on additional samples from the same lot have shown no evidence of the organism.”

Burkholderia cepacia doesn’t pose a risk to healthy individuals, according to Matrixx.

“But 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 press release said. “The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.”

Matrixx hasn’t received any reports of illness.

Zicam Extreme is a non-drip liquid nasal gel used as a nasal decongestant. It is packaged in a half-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 gel was distributed to retailers nationwide throughout the United States, according to the press release.

Matrixx said that it is notifying its distributors and retail customers by FEDEX letter and by phone and is arranging for return of all recalled products.

Consumers that have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product and contact Matrixx for a full refund.