Chattem Canada Issues Urgent Voluntary Nationwide Recall of Icy Hot(R) HEAT THERAPY(TM) Products

    MISSISSAUGA, ON, March 6 /CNW/ - Chattem Canada 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
Aspercreme(R) product.
    Chattem Canada is recalling these products in conjunction with the recall
initiated by its parent company in the U.S. (Chattem, Inc.), which has
received consumer reports of burns as well as skin irritation resulting from
consumer use, or possible misuse, of these HEAT THERAPY products in the U.S.
In Canada there have been only four, and less severe, complaints received to

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

    1. Icy Hot HEAT THERAPY Back Patch
    2. Icy Hot HEAT THERAPY Arm, Neck & Leg Patch
    3. Icy Hot HEAT THERAPY Arm, Neck & Leg single consumer use "samples"
       included on a limited promotional basis in cartons of Aspercreme Pain
       Relieving Creme, identified by a yellow sticker with the words "Bonus
       Icy Hot Heat Therapy Patch Inside" and carrying lot numbers of C2125,
       C2126 and C2127.

    If you have experienced a rash or a burn while using these products
    please discontinue their use and see your physician.

    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 Canada. 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 & Leg.

    This recall involves the above listed products only; NO OTHER Icy Hot or
Aspercreme products are included in this recall.
    Icy Hot HEAT THERAPY products contain iron oxide which produces heat on
exposure to air; all other Icy Hot products (Medicated Patches, Medicated
Sleeves and Pain Relieving Cream) contain Methyl Salicylate and/or Menthol as
the active ingredients, not iron oxide. The technologies and products are
totally different.
    Single consumer use "samples" of Icy Hot HEAT THERAPY Arm, Neck & Leg
Patches were included on a limited promotional basis in cartons of Aspercreme
Pain Relieving Creme. The samples were distinct and stand-alone products,
clearly labeled as "Icy Hot Heat Therapy Arm, Neck & Leg Patch," with their
own internal labeling.
    These products are sold over the counter through drugstores, supermarkets
and mass merchandisers.
    Product may be returned for a full refund (average retail price) by
calling Chattem Canada at 905.821.4975 (Monday - Friday from 8am to 4pm EST).
    Consumers with questions or concerns about this product may contact
Chattem Canada at 905.821.4975 (M-F 8am to 4pm EST).
    Managing marketed health product-related adverse incidents depends on
health care professionals and consumers reporting them. Reporting rates
determined on the basis of spontaneously reported post-market adverse
incidents are generally presumed to underestimate the risks associated with
health product treatments. Any cases of serious burns or other serious or
unexpected adverse incidents in patients using Icy Hot HEAT THERAPY should be
reported to Chattem Canada or Health Canada at the following addresses:

    Chattem Canada
    2220 Argentia Rd.
    Mississauga, ON L5N 2K7

    Any suspected adverse incident can also be reported to:
    Health Products and Food Branch Inspectorate
    Address Locator: 2003D
    Ottawa, Ontario K1A 0K9
    Tel: The Inspectorate Hotline: 1-800-267-9675

    The Medical Devices Problem Report Form and Guidelines can be found on
    the Health Canada web site.

    For other inquiries related to this communication, please contact Health
    Canada at:
    Marketed Health Products Directorate (MHPD)
    Tel: 613-954-6522
    Fax: 613-952-7738

For further information:

For further information: Stephen Williams, Director of Marketing,
Topical Analgesics, Chattem Canada, (905) 821-4975 x225

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