• Amit Gupta RPh, Pharm.D, CCP

Amneal and Impax Laboratories epinephrine auto-injector device malfunctions

The forwarded message below is from the FDA with regards to Impax/Amneal Epinephrine auto injectors and device malfunctions.  As most Surgery Centers have Epinephrine auto-injectors, "FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present."


FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. In letters to health care professionals and consumers, Impax Laboratories LLC, a subsidiary of Amneal Pharmaceuticals LLC, the manufacturer of the epinephrine auto-injector, detailed how certain lots of these devices might not contain the yellow “stop collar” component. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient. It is vital for lifesaving products to work as designed in an emergency situation. Patients, pharmacists and health care professionals who have received Amneal or Impax’s epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by:

  1. Removing the auto-injector from the carrying case

  2. Placing the auto-injector on a flat surface.

  3. Locating the edge of the label that states, “Peel here for further instructions.” Lift the label edge until you see the clear part of the auto-injector.

  4. Looking for the yellow “stop collar” inside the clear part of the auto-injector. If the yellow “stop collar” is not visible inside the clear part of the auto-injector, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to observe if the yellow “stop collar” comes into view inside the clear part of the auto-injector.

  5. If yellow “stop collar” is present, then the product is safe to use, and no further action is necessary. Re-wrap the label to its original position and place the auto-injector into the carrying case.

Patients and health care professionals should contact the Amneal Drug Safety Department at 1(877) 835-5472 to assist in determining if the yellow “stop collar” is missing and to make arrangements to return defective devices and obtain a replacement at no additional cost. Patients should contact their pharmacy regarding a replacement epinephrine auto-injector before returning the defective device to Amneal.

Learn More

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.


6 views0 comments

Call Us:  908-334-5437

Amit Gupta Consulting, LLC

Bordentown, NJ 08505