Pfizer Consumer Healthcare is voluntarily recalling one lot of its ThermaCare® HeatWraps Menstrual distributed in the United States and Puerto Rico.
The company 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.
Consumers who have purchased and are still in possession of the affected product should 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 Pfizer Consumer Healthcare at the number above or the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
•Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
•Mail to: MedWatch 5600 Fishers lane, Rockville, MD 20852-9787
•Fax: 1-800-FDA-0178
The lot number of the products involved is:
Lot # Exp. Date Product Name
E06831 8/2012 ThermaCare® HeatWraps Menstrual
The 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.
