FDA Announces Recall of Selected Zicam Extreme Congestion Relief Nasal Gel

December 19, 2012

The U.S. Food and Drug Administration (FDA) has notified consumers of a voluntary recall of a selected lot of Zicam® Extreme Congestion Relief nasal gel by Matrixx Initiatives.

Matrixx initiated the recall after the company found a small amount of the bacteria Burkholderia cepacia (B. cepacia) in a single sample of the product taken from the affected lot. Tests on additional samples from the same lot have shown no evidence of B. cepacia.

The recall is for Zicam Extreme Congestion Relief, lot 2J23, expiration 09/15.

The product is a non-drip liquid nasal gel used as a nasal decongestant. It is packaged in a 0.5-oz. spray bottle and contained in an outer carton that has the NDC number 62750-005-10. The product was distributed to retailers nationwide throughout the United States.

Consumers who have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product. People with cystic fibrosis who have used the recalled product should speak with their CF physician or health care provider.

B. cepacia in a nasal spray could cause upper airway colonization by the bacteria and could lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as CF. B. cepacia is resistant to many antibiotics and may be difficult to eradicate in these individuals if an infection occurs.

To view a photo of the recalled product, visit the FDA website.

To get a full refund, call Matrixx at 1-877-942-2626, 8 a.m. – 8 p.m. (Central time), Monday – Friday, and 9 a.m. – 1 p.m., Saturday.

For more information on the recall, call Matrixx at 1-877-942-2626 at the times above or visit www.zicam.com.

For more information, read the FDA announcement.