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FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
FOR IMMEDIATE RELEASE -- Minneapolis, MN -- May 18, 2005 -- The Master's Miracle (TMM) company of Minneapolis, Minn., is alerting the public against applying the company's TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer to the eyes because these products may be contaminated with Pseudomonas aeruginosa, Pseudomonas flourescens/putida and Enterobacter cloacae -- bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. The products are labeled as a Dietary Supplement and distributed nationwide in 8 oz., 20 oz. and one-gallon size containers.
It has come to FDA's attention that certain TMM distributors are actively promoting these products for ophthalmic use (in the eyes), including treatment for cataracts and allergy symptoms. FDA requires that all ophthalmic products be sterile. TMM products are not sterile and should not be applied to the eyes. TMM has agreed with FDA that, in the future, its distributors must use only company-approved marketing materials and claims for product use for its family of products. In addition, TMM will require its distributors to cease distribution or use of, and destroy any and all marketing materials that make claims for ophthalmic use of the Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer products.
TMM's mission is to offer natural, synthetic-free products, and the company's foremost concern is the well-being of its consumers. TMM is working with a well-known, independent laboratory and an expert from the University of Minnesota to identify the source of these bacteria and eliminate them.
Consumers with questions are asked to call The Master's Miracle at (763) 493-3200 for information.
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