Pfizer Consumer Healthcare, a business of Pfizer, Inc., announced today a voluntary 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 products involved is:
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.com9 or call 1-800-323-3383, Monday through Friday, 9am to 5pm est.
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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 program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm 10
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm11.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787