FDA Releases Alert for Amneal and Impax Epinephrine Auto-Injector Device Malfunctions

June 3, 2020

Impax requested that pharmacists who have dispensed Impax’s epinephrine injection, USP auto-injector 0.3 mg since December 20, 2018 contact all patients who received the device and provide instructions for inspection.

The FDA has released an alert to patients, caregivers, and health care professionals about inspecting some lots of Amneal and Impax epinephrine auto-injector 0.3 mg to make sure the device has its yellow “stop collar.”1

The yellow “stop collar” is 1 of several components that work together to confirm proper dosing of the auto-injector but may not be present in some devices, according to an Impax Laboratories, LLC letter sent to health care providers. Without the stop collar, the auto-injector can potentially deliver an overdose of 0.6 mg instead of 0.3 mg, and may cause harm to the patient or death.2

Impax is a subsidiary of Amneal Pharmaceuticals LLC, the company that manufactures the epinephrine auto-injector.1

In a letter to health care professionals, Impax requested that pharmacists who have dispensed Impax’s epinephrine injection, USP auto-injector 0.3 mg since December 20, 2018 contact all patients who received the device and provide their consumer letter, which has instructions for inspecting the yellow “stop collar.”1

Additionally, pharmacists should inspect the products before dispensing them to patients to ensure that the yellow “stop collar” is present. Those who received the device after December 20, 2018 should immediately take the following precautions to determine if the device is missing the yellow “stop collar”:

  • Remove the auto-injector from the carrying case

  • Place the auto-injector on a flat surface

  • Locate the edge of the label stating, “Peel here for further instructions.” Lift the label edge until you see the clear part of the device

  • Look for the yellow “stop collar” inside the clear part of the device; if the yellow “stop collar” is not visible there, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to see if the yellow “stop collar” comes into within the clear part

  • If yellow “stop collar” is there, the device is safe for use and no further action is needed. Re-wrap the label to its original position and place the device into the carrying case

If patients and health care professionals take these steps and fail to find the “stop collar,” they should contact the Amneal Drug Safety Department at 1 (877) 835-5462 for assistance in confirming malfunction and in making arrangements for returns.2

The FDA added that the devices have not been recalled; the agency urged patients to use the device they have on hand, but to be aware of potential malfunctions by taking action with the above listed steps.1