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Published On: Wed, Dec 19th, 2012

Zicam nasal gel recalled due to Burkholderia cepacia risk

Zicam® Extreme Congestion Relief nasal gelImage/FDA

Zicam® Extreme Congestion Relief nasal gel
Image/FDA

Matrixx Initiatives has announced they are initiating a voluntary recall of 1 lot of Zicam Extreme Congestion Relief nasal gel after the bacterium, Burkholderia cepacia was found in  a single sample of the product during a routine review at the manufacturing facility, according to an Food and Drug Administration (FDA) firm press release Tuesday.

The affected 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.

Tests on additional samples from the same lot have shown no evidence of the organism. Matrixx has not received any reports of illness.

According to the US Centers for Disease Control and Prevention, Burkholderia cepacia [burk–hōld–er–uh si–pay–shee–uh] (also called B. cepacia) is the name for a group or “complex” of bacteria that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics.

The contaminating organism pose little risk to healthy individuals, as their bodies are able to successfully fight off infections. For someone whose immune system has been weakened by other serious illnesses, especially cystic fibrosis, these bacteria can cause serious infections, including pneumonia and blood infection.

Historically, transmission of B. cepacia from contaminated medicines and devices has been reported to include everything from contaminated nasal spray to contaminated mouthwash.

In addition, B. cepacia can be spread via person-to-person contact, contact with contaminated surfaces and exposure to the bacterium in the environment.

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.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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