Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aDC21YXDGWvY
Matrixx Said It Didn’t Give 800 Zicam Reports to FDA
By Shannon Pettypiece
June 18 (Bloomberg) -- Matrixx Initiatives Inc. said today it didn’t turn over to U.S. regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.
Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning “a surprise,” during a conference call with analysts. ...
“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”