Pfizer Consumer Healthcare, a business of Pfizer, Inc., just issued a voluntary recall of one lot of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">ThermaCare HeatWraps Menstrual Product distributed in the United States and Puerto Rico, the US Food and Drug Administration (FDA) announced.
Pfizer 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 one recalled lot below. No other ThermaCare products are impacted. Pfizer has notified the FDA:
â€¢ ThermaCare HeatWraps Menstrual: Lot Number E06831; Expiration Date 8/2012.
This lot number is listed on both the outer carton and the foil pouch; the lot number may be followed by either an â€œSâ€ or an â€œN.â€ For more information on the recall and where to find this information on the package please visit www.thermacare.com or call, toll-free, 1-800-323-3383, Monday through Friday, 9:00 a.m. to 5:00 p.m., Eastern Standard Times.
Pfizer Consumer HealthCare is removing the recalled product in question from store shelves and is 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. 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.