Icy Hot is apparently too hot.  Chattem, Inc. announced today that it is initiating a voluntary nationwide recall of its Icy Hot Heat Therapy products because some consumers have experienced serious side effects, including third-degree burns, after using the defective devices.  Consumers with an Icy Hot Heat Therapy product should quit using it immediately and either dispose of it or return it to Chettem, Inc. The Icy Hot Heat Therapy recall does not include other Icy Hot products.

Icy Hot Heat Therapy products are air-activated self-heating disposable devices designed to relieve muscle and joint pain.  Chattem is recalling these products 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.

All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:

1. Icy Hot Heat Therapy Air Activated Heat- Back
2. Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg
3. Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg single consumer use “samples” included on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Crème.

The recalled Icy Hot Heat Therapy products are packaged in a red colored plastic pouch which states Icy Hot Heat Therapy and either Back or Arm/Neck and Leg. Single consumer use “samples” of Icy Hot Heat Therapy- Arm, Neck and Leg were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as “Icy Hot Heat Therapy Air Activated Heat,” with their own internal labeling. These products are sold over the counter through food, drug and mass merchandisers.

Chattem said that in September it had added more information on the product’s label about how to use them, and it expanded the warnings to help prevent consumers from misusing Icy Hot Heat Therapy. After recent discussions with the Food and Drug Administration, however, Chattem said it decided on the recall for the Icy Hot Heat Therapy products.

The company said that “after further study,” it may introduce a new Icy Hot Heat Therapy product, but right now it can’t say whether or when it might do so.

Consumers with a recalled Icy Hot Therapy product can return it to Chettem, Inc. for a full refund  by calling Chattem’s Consumer Affairs Department at 1-888-458-3487 (M-F from 8am to 4pm EST) or via our website at www.Chattem.com.

This entry was posted on Monday, February 11th, 2008 at 12:30 pm and is filed under Defective Medical Devices, Legal News.