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MAGNA-BON INITIATES CLASS I AND CLASS II RECALLS OF SIX OTC ANTISEPTICS

This article was originally published in The Tan Sheet

Executive Summary

MAGNA-BON INITIATES CLASS I AND CLASS II RECALLS OF SIX OTC ANTISEPTICS via a March 15 letter, according to the Okeechobee, Fla.-based manufacturer. The recalls were undertaken because the products, which have a low pH, may cause chemical burns, permanent injury and scarring when used as directed, according to FDA. The agency issued a warning letter to Magna-Bon on March 1 after filing a health hazard evaluation in February. The products were sold in retail outlets in 11 states -- California, Colorado, Connecticut, Florida, Georgia, Kentucky, Maryland, Michigan, Pennsylvania, Texas and Virginia -- for prices ranging from $ 3 to $ 10. No injuries associated with the products have been reported to FDA. Since Magna-Bon began marketing the products in 1985, the only consumer complaints filed with the company were five incidents of rashes, which FDA said were caused by allergic reactions to one of the ingredients, sulphur. Literature accompanying the items bears a warning against use by those allergic to sulphur, Magna-Bon noted. The Class I recalls are of Magna-Bon Antiseptic Cream, with pH 1.2 to 1.24, Facial Cream (pH 1.2 to 1.23) and Burn Spray (pH .7 to .75). The Class II recalls are of Magna-Bon Magnum Strength, Medium Strength and Mild Strength, which have the same formulations as the original products but different labels and use indications. Magna-Bon relabeled its products in January to state that they "assist the skin's healing process for minor cuts and burns" and help "clear up acne, skin blemishes and other fungal related ailments," FDA said. The previous labels had listed a wider range of indications including sunburn, acne, cold sores, diaper rash, warts and the "control of bacteria," viruses and fungi, according to FDA. The company said the original versions are being phased out. The FDA warning letter states that the original products are unapproved new drugs because they are formulated with a "non- toxic" form of sulfuric acid and ammonium sulfate and "achieve their intended healing effects through 'the control of bacteria, viruses and fungi' from the low pH provided by the sulfuric acid component." The items also are misbranded, the agency said, because labels fail to "bear adequate directions for use for the conditions for which they are offered" and do not list sulfuric acid and ammonium sulfate as active ingredients. Magna-Bon indicated that it will stop selling its OTC antiseptic products in the U.S. for the time being, but plans to continue marketing the items overseas without labeling changes. The majority of the firm's business is international, and the company is currently relocating its operations to another country. Magna-Bon also manufactures speciality chemicals.

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