On June 18,2009 Matrix Initiatives, Inc. (the manufacturer of Zicam) said it didn’t give the U.S. Food & Drug Administration (FDA) 800 consumer complaints about adverse events linked to the recalled Zicam nasal spray and gel products. The reports were found during a routine FDA inspection.
Breaking News June 25, 2009 — Zicam® Recall: SEC & FDA Investigates Matrixx
The FDA warned consumers on June 16, 2009 that the now recalled or withdrawn Zicam products could lead to the loss of smell in some users. The FDA Zicam warning was prompted by more than 130 consumer complaints made directly to the FDA regarding the subsequent loss of smell after using a Zicam product. The Zicam products that were recalled are as follows:
- Zicam Cold Remedy Nasal Gel
- Zicam Cold Remedy Nasal Swabs
- Zicam Cold Remedy Swabs, Kids Size
Manufacturer Calls the FDA Zicam Warning “A Surprise”
Bloomberg has reported, “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.”
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