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

Bundled Lots

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 pharmacovigilance@nafdac.gov.ng

NAFDAC………….Safeguarding the health of the Nation!!!