DETROIT – There's a recall of Zicam Extreme Congestion Relief nasal gel.
Matrixx Initiatives is the manufacturer of the gel and its says a small amount of a bacteria called Burkholderia cepacia was found in a sample of the affected lot.
Recommended Videos
Tests on additional samples showed no evidence of the organism.
What is it?
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.
Check your bottles
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.
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 8am-8pm Central Time Mondays-Fridays and 9am-1pm 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 www.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.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
