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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Chattem Issues URGENT Voluntary Nationwide Recall of Icy Hot® Heat Therapy™ Products

 

Contact:
Chattem, Inc.
1-888-442-4464

 

FOR IMMEDIATE RELEASE -- Chattanooga, TN -- February 8, 2008 -- Chattem, Inc. announced today that it is initiating a voluntary Nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme® product. This recall is being conducted to the consumer level.

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.

NOTE: if products have been removed from their holding cartons the recalled 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.

Consumers who have the Icy Hot Heat Therapy products under recall should immediately stop using the products, discard them, and/or return them to Chattem, Inc.

Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-877-742-6275 (M-F from 8am to 4pm EST) or via our website at www.Chattem.com.

Any adverse reactions experienced with the use of the Icy Hot Heat Therapy products should also be reported the FDA Adverse Event Reporting Program, either online at www.fda.gov/Safety/MedWatch/default.htm, or by fax at 800-FDA-0178, and to Chattem at the above toll-free number.

Chattem is notifying its customers, including distributors and retailers, about this recall, and is arranging for immediate return of all recalled products to Chattem.

This recall only involves the above listed Icy Hot Heat Therapy products including single consumer use "samples" that were included in cartons of 3 oz. Aspercreme Pain Relieving Crème and does not involve any other Icy Hot or Aspercreme products.

Chattem is committed to the integrity and safety of its products and is undertaking this voluntary recall with the full knowledge of the Food and Drug Administration.

Consumers with questions or concerns about this product may contact Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST).

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