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.
Chattem’s shares fell 2.76 percent after the letter’s release Tuesday, closing at $61.01.
Mr. Bosworth said the instances involving the product reported to the FDA ranged from skin irritation to third degree burns.
“We’d done testing and didn’t see any indication of heat-related problems,” he said.
The Chattem president said the product was a successful one liked by 99.9 percent of users.
“We’re evaluating whether we’ll relaunch a product like that,” he said. “Before we did, we’d go to the FDA to get their blessing.”
The FDA issued the letter, released Tuesday but dated June 6, after inspecting the company’s Chattanooga plant in February.
Mr. Bosworth said the letter is part of the FDA’s usual process.
“We’ll respond to the FDA about the manner in which we handle complaints and provide documentation,” he said.
Mike Pare, the deputy Business editor at the Chattanooga Times Free Press, has worked at the paper for 27 years. In addition to editing, Mike also writes Business stories and covers Volkswagen, economic development and manufacturing in Chattanooga and the surrounding area. In the past he also has covered higher education. Mike, a native of Fort Lauderdale, Fla., received a bachelor’s degree in communications from Florida Atlantic University. he worked at the Rome News-Tribune before ...
