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
Contact: Negin Kamali 213-438-8785
|SOURCE Matrixx Initiatives, Inc.|
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