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Icy Hot Heat Therapy products recalled
18 Feb '08
4 min read
Chattem Inc, a leading marketer and manufacturer of branded consumer products announced that it has initiated a voluntary recall to the consumer level of its Icy Hot Heat Therapy product.
Icy Hot Heat Therapy, launched in December 2006, is an air-activated, self-heating disposable device for the temporary relief of muscular and joint pain. 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.
Based upon the Company's review of these reports in consultation with a medical expert, Chattem believes the reported injuries are temporary or medically reversible. The number of adverse events reported to date represents less than 1/10th of one percent of the approximately 1.8 million units of product sold at retail.
In September 2007, Chattem 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.
After recent consultation with the FDA, in which the FDA suggested that further action was needed, the Company decided to initiate the voluntary recall of all Icy Hot Heat Therapy products. The recall is intended to eliminate the potential risk of the reported claims occurring to other consumers.
The recall does not affect Chattem's other topical pain care products, including other Icy Hot products. The mechanism and purpose of the Company's other Icy Hot products are fundamentally different from Icy Hot Heat Therapy. Because of these differences, the Company does not expect this recall to have a material effect on sales of its other topical pain care products. After further study, the Company may introduce a new Icy Hot Heat Therapy product, but it is not now known when or whether such product will be introduced.
Icy Hot Heat Therapy, launched in December 2006, is an air-activated, self-heating disposable device for the temporary relief of muscular and joint pain. 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.
Based upon the Company's review of these reports in consultation with a medical expert, Chattem believes the reported injuries are temporary or medically reversible. The number of adverse events reported to date represents less than 1/10th of one percent of the approximately 1.8 million units of product sold at retail.
In September 2007, Chattem 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.
After recent consultation with the FDA, in which the FDA suggested that further action was needed, the Company decided to initiate the voluntary recall of all Icy Hot Heat Therapy products. The recall is intended to eliminate the potential risk of the reported claims occurring to other consumers.
The recall does not affect Chattem's other topical pain care products, including other Icy Hot products. The mechanism and purpose of the Company's other Icy Hot products are fundamentally different from Icy Hot Heat Therapy. Because of these differences, the Company does not expect this recall to have a material effect on sales of its other topical pain care products. After further study, the Company may introduce a new Icy Hot Heat Therapy product, but it is not now known when or whether such product will be introduced.
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