Feb. 11, 2008— -- The government says some consumers got more heat than they bargained for when they applied Icy Hot Heat Therapy packs for relief from achy limbs — and instead received serious burns.
The Food and Drug Administration announced today that Chattem, Inc., of Chattanooga, Tenn., is recalling several varieties of its Icy Hot Heat Therapy Air-Activated Heat patches "because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products."
The thin packs warm up when opened and marketing claims include that they "provide up to 8 hours of continuous warmth" to "provide effective temporary relief of muscular and joint pain associated with arthritis, simple backache, muscle strains and sprains."
A spokeswoman for Chattem said the recall involves approximately 1.8 million boxes of patches and includes all lots and all sizes of the packs labelled for use on the back and those for arm, neck and leg. Some of the packs — single-use samples of the arm, neck and leg variety — were included as free promotions in 3-ounce cartons of Aspercreme Pain Relieving Crème.
The FDA warns consumers to immediately stop using the products and either toss them out or mail them to Chattem for a refund. The company also has provided a toll-free number for consumers: 1-888-458-3487.
An FDA official said the agency had no further information on the number of products recalled. In a press release issued to investors, Chattem said "the reported injuries are temporary or medically reversible."
The company also assured investors that while the recall would cost the company $6-$9 million, the number of burns reported "represents less than one-tenth of one percent of the approximately 1.8 million units of product sold at retail."
Chattem spokeswoman Catherine Baker told ABC News that 200 "adverse events" involving the patches have been reported to the FDA over the past 13 months. And most of the burn injuries, she said, happened when the product wasn't used properly.
Chattem says it has been aware of potential problems since the patches were introduced in December 2006.
"Since its introduction, the Company has received some consumer reports of first, second and third degree burns and skin irritation resulting from the use or possible misuse of the product," Chattem said in the statement to investors.
The following autumn, Chattem said, it "began shipping product that included more information on the product's label in order to clarify the directions for use and added expanded warnings and precautionary statements to further guide the consumer as to proper product usage and to prevent product misuse."
But the FDA, according to Chattem's note to investors, recently "suggested that further action was needed."