Zicam failed to send government side effect complaints
Makers of Zicam nasal sprays and swobs, Matrixx Initiatives Inc. Failed to send 800 customer complaints to US regulators concerning the use of its products. The company stopped selling Zicam on 16th June after the Food and Drug Administration (FDA) put out a health warning saying that the products may cause loss of smell.
During a conference call with Matrixx analysts they said it was a “surprise” when the FDA put out the health warning.
During a routine inspection back in May the FDA found 800 reports of consumer complaints regarding the two products. Acting president and chief operating officer of Matrixx, William Hemelt said during the conference call that he was told by lawyers that the 2007 regulation did not apply to the complaints they had received.
“We have complaints but we weren’t required to send them. 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,” Hemelt said.
The company are now in the process of recalling the affected merchandise which they estimate will cost them $10 million as well as increasing product liability. Late last week the company took down their sales and earnings forecast for next year.
Thanks to www.bloomberg.com for the above quotes.