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Chattem warned about Icy Hot

This article was originally published in The Tan Sheet

Executive Summary

FDA issues a warning letter to Chattem June 6 regarding misbranding of the company's Icy Hot Heat Therapy patches and inadequate procedures for implementing corrective action once the firm began receiving complaints about burns and skin damage linked to use of the product. The letter, sent by FDA's New Orleans District Office to Chattem President Robert Bosworth, details the lack of adequate directions for use and warnings on the product's labeling, and states Chattem failed to notify FDA of a labeling change instituted once consumer health risks emerged. The company also did not report in a timely fashion on complaints the patches caused injury. Chattanooga, Tenn.-based Chattem voluntarily recalled the Icy Hot Heat Therapy patches in February, six months after adding expanded warnings and precautions to the label (1"The Tan Sheet" Feb. 18, 2008, p. 5)...

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