Zicam Recall Result of FDA Warning

FDA's warning applies to Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size, but does not affect Zicam oral zinc tablets or lozenges.

"The biggest unknown is the degree to which the sales of our products (are) maintained," Hemelt said.

Matrixx is seeking a meeting with FDA officials with the hope of reversing the agency's decision, Hemelt said, adding that several studies showed no loss of smell with nasal Zicam products and arguing that FDA's conclusions were "erroneous."

While Hemelt said Tuesday's warning came as a "complete surprise," he said the company had been visited in May by FDA inspectors who drew attention to about 800 reported complaints that had not been given to the agency.

A law passed in 2007 required wider mandatory reporting of certain products, but Hemelt said the company did not send along the reports based on the opinion of its lawyer.

If the company's efforts fail to persuade the FDA, Matrixx will have to downsize, Hemelt said. "Obviously, we have to learn how to shrink this company if we're unable to get these products back on the shelf."

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