Wednesday, December 19, 2012
A New Jersey pharmaceutical company has recalled an over-the-counter cold remedy.
Matrixx Initiatives is voluntarily recalling one lot of Zicam Extreme Congestion Relief nasal gel, according to the U.S. Drug and Food Administration.
The company announced the move this week after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot.
Burkholderia cepacia is a bacteria usually found in soil and water. Although the organism poses little medical risk to healthy individuals, when administered in a nasal spray, it can cause upper airway colonization and lead to respiratory infections in users with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis.
The bacteria is resistant to many antibiotics and may be difficult to kill in sensitive populations if an infection occurs.
There are no reported illnesses related to the nasal get to date, according to the company. Tests on additional samples from the same lot have shown no evidence of the organism.
The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a half-ounce spray bottle contained in an outer carton, bearing NDC No. 62750-005-10. The affected lot is “2J23, Expiration 09/15.” The product was distributed to retailers nationwide.
Matrixx is notifying distributors and retail customers by Fedex and by phone, arranging for return of recalled products. Consumers in possession of the gel should stop using the product and contact Matrixx for a full refund at 877-942-2626.