Zicam Recall Linked To Loss Of Smell

FDA - Matrixx Initiatives Inc. said Wednesday it started a previously announced recall of Zicam nasal cold remedies following last week’s Food and Drug Administration warning that the products were unsafe.

Meanwhile, the company is being investigated by the Securities and Exchange Commission over the FDA warning letter.

The Scottsdale, Ariz., company said the recall was voluntary. Still, it occurred as the FDA warned consumers to not use the nasal cold remedies due to hundreds of reports of patients losing their sense of smell. Matrixx said it disagrees with the FDA’s safety warning, but “voluntarily” recalled the product to cooperate with the regulatory agency.

The FDA also alleges the products were unlawfully marketed. Matrixx also disagrees with that allegation.

“The company is also in the process of preparing a submission to the FDA and, as previously reported, will soon ask to meet with the agency to present comprehensive scientific and medical data and analyses demonstrating that these products are safe,” Matrixx said, in a statement.

On June 16, the FDA issued the recall notice for Zicam products, which accounted for 40 percent of Matrixx’s sales last year. The regulatory agency said the products contain zinc, which could damage nerves in the nose needed for smell.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, though it maintains the nasal spray does not harm users’ sense of smell.

Shares of Matrixx rose 3 cents to $4.86 in morning trading. The stock has lost three-quarters of its value since the FDA issued its warning last week.