date:Feb 16, 2013
tly 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, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.