STATEN ISLAND, N.Y. -- Pfizer is voluntarily recalling one lot of its ThermaCare heat wraps due to a possible burn risk, according to the U.S. Food and Drug Administration (FDA).
Pfizer Consumer Healthcare, a division of Pfizer Inc., issued the recall for the ThermaCare Back Pain Therapy HeatWraps, up to 16-hour pain relief, according to the notice.
The company initiated the recall due to the potential that the heat wrap could include cells that have a higher cell temperature than specified, the FDA said.
The use of a wrap with a cell with increased temperature poses a potential risk of skin injuries such as burns and blisters and/or skin irritation on the wrap applied area, the notice said.
The product label recommends the user to stop use or wear a layer of clothing if the product feels too hot to prevent skin injuries, according to the FDA.
The heat wraps provide heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, strains, sprains and arthritis.
The heat wrap master lot impacted is S97473, UPC 305733010037 (Lower Back and Hip Therapy, 2 count carton) and was used in the manufacturing of 17 retail display case sub lots, the FDA said.
The products were distributed nationwide from June 2017 to March 2018.
Consumers should contact their healthcare provider if they have experienced any problems that may be related to using this product, the notice said.
Pfizer is removing the recalled products from store shelves and asking consumers who have purchased the product to discontinue use, record the lot number, and throw the product away.
Consumers can call the Pfizer Consumer Healthcare Information Line at 1-800-323-3383 for replacement or reimbursement.
This is the second recall of the products since November when Pfizer recalled six lots of its heat wraps because the products may leak ingredients, causing burns and blisters and/or skin irritation.
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