Parker Waichman LLP

Icy Hot Heat Therapy Patch Recall Elicits FDA Warning Letter

The maker of < "https://www.yourlawyer.com/practice_areas/defective_medical_devices">Icy Hot Heat Therapy patches has been issued a warning letter from the Food & Drug Administration (FDA) for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. Chattem, Inc. recalled Icy Hot Heat Therapy products earlier this year […]

The maker of < "https://www.yourlawyer.com/practice_areas/defective_medical_devices">Icy Hot Heat Therapy patches has been issued a warning letter from the Food & Drug Administration (FDA) for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. Chattem, Inc. recalled Icy Hot Heat Therapy products earlier this year after some consumers suffered burns after using the products.

The FDA warning letter stemmed from an inspection of the company’s Chattanooga, Tennessee plant conducted from Feb. 5 through Feb 8. The Icy Hot Heat Therapy products were recalled on Feb. 8.  The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems cited in the warning letter.

Icy Hot Heat Therapy products are air-activated self-heating disposable devices designed to relieve muscle and joint pain. Chattem recalled the products after it had received some consumer reports of first, second and third degree burns as well as skin irritation related to their use.  Involved in the Icy Hot recall were:

  • 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 3 oz. Aspercreme Pain Relieving Creme.

Chattem said that in September it had added more information on the product’s label about how to use them, and it expanded the warnings to help prevent consumers from misusing Icy Hot Heat Therapy. However, according to the FDA warning letter dated June 6, Chattem did not inform the agency of those label changes in a timely manner. The company also did not report some complaints to the agency within the time period required by law.

The FDA warning letter also faulted the Icy Hot Heat Therapy products’ label for a number of inadequacies.  For example, the FDA said the label did not properly explain its warnings or caution that certain users such as children should not use the patches. The label also said the patches could be used for  “up to 8 hours”, which the FDA said “raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch.”

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality I want to say thank you to Denny Tang for handling my case. He’s a great attorney, always responsive and pleasant to speak with. Thank you for everything.
Leyla Coello
3 years ago
5 Star Reviews 150
Thank you to the lawyers Parke Waichman for their professionalism, especially to Jorge Peniche, a person who was of great help to me in several aspects, very grateful, thank you again.....
Josue Portillo
5 years ago
5 Star Reviews 150
I am happy to choose Parker Waichman to handle my case. They are very professional and attentive, they always answer any questions I have. I also thank Denny Tang, Kathy Núñez and Jorge Peniche for making me feel comfortable with their help. Thank you for everything you are doing for me.
Francisco Aviles
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038