FDA's Q & A on Chattem, Inc. “Icy Hot Heat Therapy Air Activated Heat”

FDA has provided Questions and Answers session on recent recall Of “Icy Hot Heat Therapy Air Activated Heat”

What is “Icy Hot Heat Therapy Air Activated Heat”?

Icy Hot Heat Therapy Air Activated Heat is an adhesive patch that generates heat. The patch comes in a red sealed plastic pouch. Once the pouch is opened and the patch is exposed to air, the chemicals contained in the patch activate to produce heat. It is then applied to body surfaces to relieve muscle and joint pain associated with arthritis, backache, muscle strains and sprains.

What is the problem with Icy Hot Heat Therapy Air Activated Heat products?

Chattem, Inc. chose to recall their Icy Hot Heat Therapy products because they received consumer reports of first, second and third degree burns as well as skin irritation and skin removal resulting from the use of the Icy Hot Heat Therapy Air Activated Heat patch. As part of FDA's recall classification process, we will be reviewing the firm's root-cause analysis on what caused the burns.

What is the difference between first, second and third degree burns?

The type of burn is determined by how deeply it penetrates into the skin. There are two main layers of skin, and the degree of burn is based on how each layer is affected. First degree burns are the least severe and third degree burns are the deepest or most severe.

First Degree Burns: Means the top layer of skin (the epidermis) is damaged but not destroyed and turns bright pink or very red. Pain from first degree burns ranges from mild to extreme. No skin comes off and there are no blisters. Mild sunburns are a good example of first degree burns.

Second Degree Burns: Means burn damage has gone through the top layer (the epidermis) and into the 2nd layer of skin (the dermis). The top layer of skin is destroyed and may slide off or blister. Blisters are the first sign of a second degree burn. The wound appears red or pink and moist. Second degree burns are the most painful kind of burn.

Third Degree Burns: Means the burn has destroyed both the first and second (epidermis and dermis) layers of the skin. The exposed wound appears white, gray, yellow, brown or black and is usually dry. There may be little or no pain or the area may feel numb because of nerve damage.

When were the Icy Hot Heat Therapy Air Activated Heat patches produced and sold?

The firm issued a press release, dated February 8, 2008, for their voluntary recall involving 2.3 million Icy Hot Heat Therapy Air Activated Heat patches distributed in the United State since December 2006. The products were manufactured between December 2006 and February 2008 and sold over the counter through food, drug and mass merchandisers. You can find a listing of retailers on Chattem, Inc.’s website at http://www.chattem.com/wheretobuy/icy.asp.

What products are affected by the recall?

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

• 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 in single-use “samples” that 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." This recall only involves the above listed Icy Hot Heat Therapy products and does not involve any other Icy Hot products such as the medicated patch, cream, or balm/stick that also use the “Icy Hot” name.

If the product was removed from the original carton, what does it look like?

The product inside the carton is in a red plastic pouch that says Icy Hot Heat Therapy and either Back or Arm/Neck and Leg. If you are unsure you have an affected product, you should asked the retailer where you purchased it whether your product is affected by this recall, or contact Chattem as indicated below.

What steps should I take if my patches are affected by the recall?

If you have one of the recalled products, you should stop using it immediately, and discard or return it to Chattem, Inc. Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-888-442-4464 or via their website at www.Chattem.com.

To read more about the recall:

• FDA Recall Notice at http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html

Consumers with questions may contact:

• Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST).

How do I report adverse events to FDA?

If you have experienced burns, skin irritation or other adverse reactions with the use of this product or any medical device, we encourage you to report this 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
  

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