Three Zicam products are being recalled by the Food & Drug Administration in a directive issued on Tuesday, June 16, 2009. The zinc-containing cold remedy has been identified as the reason for 130 documented cases of loss of smell.
Some consumers have reported immediately suffered the inability to smell after just one dose while others didn’t have symptoms appear until multiple doses had been self-administered.
The products Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size have been ordered pulled from store shelves across the country and the FDA advises that consumers should discard any remaining product and not use it for any reason.
The FDA fears that the gel may be causing nasal nerve damage. It has not yet been determined if the condition people are experiencing is permanent. Consumers who are experiencing any adverse symptoms are asked to contact MedWatch either on line or at 1-800-FDA-1088.
Zicam is manufactured in Scottsdale, Arizona by Matrixx Initiatives. They have 15 days to respond to the FDA allegations and have been ordered to hand over 800 user complaints that have not previously been made available to the FDA, according to their Compliance Director Deborah M. Autor. In response, Matrixx issued this statement:
“No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”
Company stock plummeted by 56% on the Nasdaq before trading was halted. It was the worst loss since its initial public offering in 1996, falling $10.68 and ending at $8.56.
Further recall information is available on the FDA website.
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