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Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs
Date:6/24/2009

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 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 www.zicam.com. To find out more about Matrixx Initiatives, Inc. (NASDAQ: MTTX), visit our Web site at 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
    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 www.zicam.com for a refund and/or questions.

                                     Zicam LLC

    Contact: Negin Kamali 213-438-8785


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SOURCE Matrixx Initiatives, Inc.
Copyright©2009 PR Newswire.
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