Bacterial contamination has been detected in some bottles of Zicam Extreme Congestion Relief nasal gel, resulting in a recall of one lot.
The FDA announced the Zicam Extreme Congestion Relief recall on December 19, after the manufacturer, Matrixx Initiatives, had a sample test positive for Burkolderia cepacia, a bacterial contaminant.
While no illnesses have been reported, the bacteria could cause respiratory infections in people with compromised immune systems or chronic lung conditions. The bacteria can often resist treatment with antibiotics.
The recall affects one lot of Zicam Extreme Congestion Relief nasal gel with a lot number of 2J23, and an expiration date of 09/15. The nasal gel is sold in 0.5 oz spray bottles and have an NDC number of 62750-005-10.
A previous Zicam recall was issued in 2009, after the FDA identified at least 120 adverse event reports involving loss of smell with Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size.
Although Matrixx Initiatives has maintained that their over-the-counter cold remedy could not be the cause for the problems, the manufacturer agreed to remove the product from the market following the FDA warning.
In the aftermath of the recall, FDA inspectors discovered 800 reports of Zicam problems that Matrixx Initiatives failed to forward to the agency, in violation of federal regulations. The products had been sold as a dietary supplement, meaning they did not fall under FDA jurisdiction until the violations.
Matrixx Initiatives faced hundreds of product liability lawsuits over loss of smell caused by the Zicam products recalled in 2009. Virtually all of the cases were settled out of court for undisclosed amounts after the manufacturer failed to get the claims dismissed.