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Report an Adverse Event

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. 

 

To report an adverse event/reaction  and/or product complaint to BDSI, call 1-800-469-0261 and select option 2  or email the following information 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 # and/or dosing information
  • Call back # 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/Saftey/MedWatch.

 

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