Pfizer Consumer Healthcare is voluntarily recall of one lot of its ThermaCare HeatWraps Menstrual product distributed in the United States and Puerto Rico.
The company said it is taking this precautionary step after finding a potential for a leak of the components contained in the wrap,which could cause skin injury such as irritation or burn. The issue is
limited to the recalled lot. No other ThermaCare products are impacted.
Pfizer has notified the U.S. Food and Drug Administration.
The lot number of the product involved is:
Lot # Exp. Date Product Name
E06831 8/2012 ThermaCare HeatWraps Menstrual
This lot number is listed on both the outer carton and the foil pouch.
The lot number may be followed by either an S or an N. For more information on
the recall and where to find this information on the package please visit
www.thermacare.com <<a href=”http://www.thermacare.com/”>http://www.thermacare.com/> or call 1-800-323-3383,
Monday through Friday, 8am to 4pm CST.
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 record the lot number, throw the product away in
its entirety without opening the foil pouch, and call 1-800-323-3383 for
replacement.
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA’s MedWatch Adverse Event Reporting at
www.fda.gov/medwatch/report.htm. A postage-paid FDA form 3500 available to
download and mail at: www.fda.gov/MedWatch/getforms.htm to MedWatch 5600
Fishers Lane, Rockville, MD 20852-9787.
