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U.S. Department of Health and Human Services

Medical Devices

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Chattem, Inc. Icy Hot Heat Therapy Products

Class II Recall
Date Recall
Initiated:
February 12, 2008
Product:

All lots and sizes of the following Icy Hot Heat Therapy Products

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

No other Icy Hot Heat Therapy products are affected by this recall.

The company manufactured these products from October 1, 2006 through July 31, 2007 and distributed them from December 4, 2006 through February 4, 2008.

Use:
These products are used for the temporary relief of muscular and joint pain associated with arthritis. They are for external use only.
Recalling Firm:
Chattem, Inc.
1715 W 38 th Street
Chattanooga, Tennessee 37409-1248
Reason for Recall:
The company recalled these products because of consumer reports of first, second, and third degree burns, skin irritation, and skin removal.
Public Contact:
Consumers with questions or concerns may call Chattem’s Consumer Affairs Department at 1-888-442-4464 (Monday through Friday) 8 am to 4 pm Eastern Standard Time.
FDA District:
New Orleans
FDA Comments:

The company began its recall on February 8, 2008, by issuing a press release warning the public of the hazard and directing them to stop using the product and either return or discard the products. Four days later, the company instructed its sales force to notify all Chattem wholesalers and retailers with instructions for consumers to stop using the product, discard them, or return them to Chattem, Inc.

This product may be returned for a full refund (average retail price). Call Chattem’s Consumer Affairs Department at 1-877-742-6275 (Monday through Friday) from 8 am to 4 pm Eastern Standard Time.

For additional information see nearby links.

Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program. See nearby link to MedWatch.