Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178)
To report a product quality complaint, please contact Theragnostics Pharmacovigilance
To place an order for NephroScan, please contact your local radiopharmacy, or you may also contact GEHC at 1-800-292-8514, 8:00 AM to 6:30 PM Eastern time, or via web portal address ci.gehealthcare.com/us
Indication: NEPHROSCAN™, after radiolabeling with technetium Tc 99m, is a radioactive diagnostic agent indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and pediatric patients including term neonates.
Important Safety Information: Radiation Risks: TechnetiumTc 99m succimer injection contributes to a patient’s overall long-term cumulative radiation exposure.