To report an adverse event/reaction and/or product complaint to BDSI, call 1-800-469-0261 and select option 1. Or email the information requested below to drugsafety@bdsi.com.

When choosing this option please have the following information ready:

• Identifiable reporter
• Identifiable patient (gender)
• Adverse reaction and/or product complaint
• Suspect lot number and/or dosing information
• Callback number and/or email

To report an adverse event/reaction directly to FDA’s MedWatch program, call 1-800-FDA-1088 (1-800-332-1088) or go to www.fda.gov/Safety/MedWatch.

If you wish to be contacted by your local BDSI representative, call 1-800-469-0261 and select option 6.

BDSI routinely collects and analyzes safety information on our products, including reports from healthcare professionals and patients about Adverse Events and Product Complaints. We submit reports as appropriate to the U.S. Food and Drug Administration (FDA) which reviews these reports.