Adverse Event Reporting

Please contact us if you experience an adverse event associated with the use of an Amneal or Impax product. The following should be reported to Amneal whether or not they are associated with an adverse event:

• Off-label use of an Amneal or Impax product relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the approved product information
• Accidental or intentional medication errors or overdose of an Amneal or Impax product
• Misuse, where the Amneal or Impax product is intentionally and inappropriately used not in accordance with the approved product information
• Abuse, which is persistent or sporadic, intentional excessive use of a medicinal product
• Reports of patient death after exposure to an Amneal or Impax product where no other details are provided
• Occupational exposure to an Amneal or Impax product
• Transmission of an infectious agent through a contaminated Amneal or Impax product

To Report an Adverse Event

If you are currently experiencing a life-threatening event, please immediately call 9-1-1.

To report an adverse event related to an Amneal, Impax and/or Gemini Laboratories Product:

Contact the Amneal Drug Safety team at (877) 835-5472, option 3 or at DrugSafety@amneal.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call (800) FDA-1088.