Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare HeatWrap product to the consumer level. Pfizer initiated the recall because product from the lots has a potential to leak ingredients that are contained in the heat cell wrap.
The use of a leaking/damaged heat cell wrap could cause skin injuries such as burns/blisters and/or skin irritation on the wrap applied area. The product label warns not to use the product if heat cell contents leak and/or the wrap is damaged or torn.
ThermaCare Muscle Pain Therapy provides heat therapy for temporary relief of minor muscular aches and pains associated with overexertion, strains, sprains, and arthritis. ThermaCare Menstrual Pain Therapy provides heat therapy for temporary relief of minor menstrual cramp pain and associated backaches.
The ThermaCare HeatWrap lots impacted are S68516 (Muscle Pain Therapy 3+1 count carton); T26686 (Muscle Pain Therapy 3 count carton); T26691 (Menstrual Pain Therapy 3 count carton); T26693 (Menstrual Pain Therapy 3+1 count carton); and 8054HA and 8054HB (11 count bundled packages contain one package of Muscle Therapy Heatwraps, 8HR/3 count and two packages of Joint Therapy Heatwraps, 8HR/4 count.)
ThermaCare Joint Therapy Heatwraps, 8HR are not subject to the recall notification.
These lots were distributed nationwide to retailers, wholesalers and distributors in the United States, Puerto Rico and the U.S. Virgin Islands from September 2017 through August 2018.
ThermaCare HeatWrap Lot and Packaging Information
|Product Name||Lot Number||Expiry Date||SKU||UPC||Configuration/Count|
|Muscle Pain Therapy 8HR||S68516||2020-07||F00573301314||305733013144||3 + 1 one-time use wraps per carton|
|Muscle Pain Therapy 8HR||T26686||2020-07||F00573301303C||305733013038||3 one-time use wraps per carton|
|Menstrual Pain Therapy 8HR||T26691||2020-07||F0057332002H||305733020029||3 one-time use wraps per carton|
|Menstrual Pain Therapy 8HR||T26693||2020-08||F00573302044||305733020449||3 + 1 one-time use wraps per carton|
|Product Name||Bundled Lot Number||Carton/ Pouch Lot Number||Expiry Date||SKU||UPC||Configuration/Count|
|Joint/Muscle Pain Therapy 8HR||8054HA||T26686||2020-07||F00573301311||305733013113||Multi-pack 11 one- time use wraps per carton|
|Joint/Muscle Pain Therapy 8HR||8054HB||T26686||2020-07||F00573301311||305733013113||Multi-pack 11 one- time use wraps per carton|
Pfizer Consumer Healthcare is notifying consumers of the recall with the public notification. The company already has notified its retailers of the recall on October 2, 2018 and has provided instructions for the return of any recalled product. Wholesalers, distributors, and retailers with an existing inventory of the lot being recalled should stop use and distribution and quarantine the product immediately.
Wholesalers, distributors, and retailers who have further distributed the recalled product should notify any accounts or additional locations that may have received the recalled product from them. For retailer instructions on returning product or additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Pfizer Consumer Healthcare is removing the product in question from store shelves and asking consumers who have purchased and are still in possession of the affected product to discontinue use of the products, record the lot number, throw the product away in its entirety without opening the foil pouch, and to contact the Pfizer Consumer Healthcare Information Line at 1-800-323-3383 (Monday-Friday, 9 a.m. to 5 p.m. ET) for replacement or reimbursement.
Note: The lot numbers can be found on the side of ThermaCare cartons and on the back of ThermaCare pouches.
(Source: Food and Drug Administration)