Drug Safety Alerts

ThermaCare® Back Pain Therapy Heatwraps - Consumer-level Recall

04/29/2019

On April 29, 2019, Pfizer Inc. issued a consumer-level recall of ThermaCare^® Back Pain Therapy Heatwraps, up to 16 HR pain relief NDC # 00573-3010-03. This recall was issued due to the potential that a HeatWrap could include cells that have a higher cell temperature than specified.

This recall affects lot number S97473 exp. 03/31/2020.

The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area. The product label recommends that the consumer stop use or wear a layer of clothing if the product feels too hot in order to prevent burns. In addition, the label instructs not to use the wrap on unhealthy, damaged or broken skin, or on areas of bruising or swelling that has occurred within 48 hours. These label instructions are intended to mitigate risk of serious events. The potential risk to a patient arising from this issue is considered to be Low-Medium.

ThermaCare^® Back Pain Therapy HeatWraps provide heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, strains, sprains, and arthritis

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using ThermaCare^® Back Pain Therapy Heatwraps to contact their prescriber.

For more information about the recall, please call Pfizer toll-free at 1-800-323-3383. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO‑FDA (1-888-463-6332) or visit www.fda.gov.