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. 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. , visit our Web site at www.matrixxinc.com.
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CONTACT: Negin Kamali, +1-213-438-8785, for Matrixx Initiatives, Inc.
Web site: http://www.zicam.com//
http://www.matrixxinc.com//