Class II Recall: Chattem, Inc. Icy Hot Heat Therapy Products

February 12, 2008

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.

These products are used for the temporary relief of muscular and joint pain associated with arthritis. They are for external use only.

The company recalled these products because of consumer reports of first, second, and third degree burns, skin irritation, and skin removal.

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) by calling Chattem’s Consumer Affairs Department at 1-877-742-6275 (Monday through Friday) from 8 am to 4 pm Eastern Standard Time or by visiting their website at www.Chattem.com.

To read FDA’s Questions and Answers about Chattem Inc. Icy Hot Heat Therapy products, please go to: http://www.fda.gov/cdrh/safety/icyhot-qa.html

For more information about this recall, please see the company’s press release at: http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html

Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178