Date Recall Initiated |
February 12, 2008 |
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Product: |
All lots and sizes of the following Icy Hot Heat Therapy Products
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) 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.
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Updated March 10, 2008
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