Resources for Food and Drug Administration (FDA)

Chattanooga: FDA issues warning letter to Chattem

timesfreepress.com

Chattem Inc. has received a warning letter from the U.S. Food and Drug Administration over its Icy Hot heat therapy patches, which were recalled earlier this year. The letter said Chattem failed to notify health officials about new labeling cautions added to the product after the company received more than 168 complaints. The letter also said Chattem did not disclose the reported problems within the time period required by law. However, Chattem President Bob Bosworth said the company did report the complaints and informed the FDA about the label changes. “It’s not from our perspective a serious new issue,” he said about the letter, adding the product is off the market.

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