Public Alert No: 0040/2018 – Thermacare Hetwraps By Pfizer: Six Lots Recalled Due To The Potential For Skin Injuries
The National Agency for Food and Drug Administration and Control has been informed that Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these 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.
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 Number /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|
NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution, and use of the recalled products.
Healthcare providers and anyone in possession of the recalled products should submit them to the nearest NAFDAC office.
Patients and healthcare providers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via firstname.lastname@example.org
NAFDAC………….Safeguarding the health of the Nation!!!