Community Corner

RECALL: Congestion Relief Nasal Gel Zicam, Possible Health Risk

The medicine is sold in drugstores in Dana Point and Laguna Niguel, as well as nationwide.One lot of the product is being recalled for safety, according to FDA.

Information provided by the United States Food and Drug Administration.

Matrixx Initiatives is voluntarily recalling 1 lot of Zicam Extreme Congestion Relief nasal gel. The company is taking this step 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. Tests on additional samples from the same lot have shown no evidence of the organism, says the FDA.

The product is sold nationwide in drugstores as well as in Dana Point and Laguna Niguel.

Find out what's happening in Laguna Niguel-Dana Pointwith free, real-time updates from Patch.

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. Matrixx has not received any reports of illness, says the FDA.

The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. 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 nationwide throughout the United States.

Find out what's happening in Laguna Niguel-Dana Pointwith free, real-time updates from Patch.

Matrixx 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 at 1-877-942-2626 from 8 a.m to 8 p.m. Central Time Mondays-Fridays and 9 a.m. to 1 p.m. Central Time on Saturdays.

Consumers with questions regarding this recall can contact Matrixx at 1-877-942-2626 at the times stated above or via the Internet at zicam.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


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