Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs
June 24 2009 - 7:30AM
PR Newswire (US)
Company Disagrees with the FDA on Product Safety Concerns,
Continues to be Committed to Cooperating with the FDA on Resolution
SCOTTSDALE, Ariz., June 24 /PRNewswire-FirstCall/ -- Matrixx
Initiatives, Inc. (NASDAQ:MTTX) has announced that it is in the
process of formally notifying retailers, wholesalers and
distributors nationwide of its recall of all Zicam Cold Remedy
Nasal Gel and Zicam Cold Remedy Gel Swabs. Matrixx Initiatives
vigorously disagrees with the FDA's allegations that these products
are not safe and that they were unlawfully marketed. However, the
company reiterated that it is conducting this recall because of its
desire to cooperate with the FDA. 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 Initiatives
immediately suspended shipments of these two products upon receipt
of the FDA's warning letter on June 16 and then announced a
voluntary nationwide withdrawal of Zicam Cold Remedy Nasal Gel and
Zicam Cold Remedy Gel Swabs that same day. The company is also
notifying retailers to stop selling Zicam Cold Remedy Nasal Gel and
Zicam Cold Remedy Gel Swabs and is asking them to post information
at point-of-sale, advising consumers of the recall and inviting
them to return these two products to Zicam for a full refund. A
copy of the recall notification is attached. The company also has
communicated on a proactive, ongoing basis with consumers since it
announced the voluntary recall of these products on June 16, 2009.
These have included full-page ads in leading newspapers,
distribution of an informational video from Matrixx Initiatives'
president, updated copy for the Zicam Web site at
http://www.zicam.com/, expanding staffing of the Zicam customer
support center, and extensive use of social media vehicles. Matrixx
Initiatives, Inc. is engaged in the development and marketing of
over-the-counter healthcare products that utilize innovative drug
delivery systems. Zicam, LLC, its wholly owned subsidiary, markets
and sells Zicam(R) products in the cough and cold category. For
more information regarding Matrixx products, go to
http://www.zicam.com/. To find out more about Matrixx Initiatives,
Inc. (NASDAQ:MTTX), visit our Web site at
http://www.matrixxinc.com/. TEMPLATE LETTER TO CUSTOMERS/RETAILERS
Contact name or Department Firm's name Address City, State, Zip
Code URGENT DRUG RECALL* RE: ZICAM(R) Cold Remedy Nasal Gel (all
lots) and ZICAM(R) Cold Remedy Gel Swabs (all lots) Dear Customer,
Matrixx Initiatives, Inc. ("Matrixx") is voluntarily recalling from
the market all lots of ZICAM(R) Cold Remedy Nasal Gel and ZICAM(R)
Cold Remedy Gel Swabs. As you may know, FDA has recently asserted
that these products are associated with the loss of smell and are
also what FDA calls "unapproved new drugs." Although we vigorously
disagree with FDA on both counts, we announced when we first heard
from FDA on this matter that we would recall these products pending
the opportunity to discuss these issues with the agency. Please
examine your shelves and warehouses to determine if you have any of
these products, in stock or in inventory. If so, discontinue
distributing the products and promptly return all units, via parcel
post, to our distribution center at: Zicam Swab/Gel Recall C/o
Jacobson Warehousing 435 S. 59th Ave Phoenix, AZ 85043 Also, please
block sale of Zicam Gels and Swabs at cash registers and post the
enclosed posters on or near the shelves where Zicam Gels and Swabs
were previously shelved and at cash registers and other appropriate
locations throughout your stores. Retailers should instruct
consumers to contact Matrixx directly by phone at 877-942-2626 or
by Internet at http://www.zicam.com/ for a refund. Please return
the enclosed Return Response Form to Matrixx Initiatives PO Box
28486 Scottsdale, AZ 85255 or Fax to: (602) 385 8850 Matrixx
apologizes for any inconvenience this recall has caused. Should you
have any questions, please contact us at 602-385-8856. Sincerely,
Lou Fraser Director of Quality Assurance Zicam, LLC * FDA often
classifies recalls as Class I, II, or III on the basis of the
degree of risk it believes the product presents to the consumer.
Because we believe Zicam Gels and Swabs are safe and do not present
any risk, we have not classified or described this recall as Class
I, II, or III. As noted above, we do not agree with FDA about risk.
We are conducting this recall voluntarily as a signal of our
willingness to cooperate with the agency. Please note: Recall
Return Response Form available upon request RECALL Zicam(R) Cold
Remedy Nasal Gel Zicam(R) Cold Remedy Gel Swabs (Photo:
http://www.newscom.com/cgi-bin/prnh/20090624/LA37416) -- Consumers
should discontinue use and discard unused product. -- Call our
toll-free customer service number (877-942-2626) or visit our
website at http://www.zicam.com/ for a refund and/or questions.
Zicam LLC Contact: Negin Kamali 213-438-8785
http://www.newscom.com/cgi-bin/prnh/20090624/LA37416
http://photoarchive.ap.org/ DATASOURCE: Matrixx Initiatives, Inc.
CONTACT: Negin Kamali, +1-213-438-8785, for Matrixx Initiatives,
Inc. Web Site: http://www.zicam.com/
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