FDA: Certain Epinephrine Autoinjector Devices May Have Missing Safety Component

Certain lots of Amneal’s Epinephrine Injection, Autoinjector 0.3mg may not contain the yellow “stop collar” that is necessary for proper dosing of the anaphylaxis treatment, according to the Food and Drug Administration (FDA). 

In a letter to health care professionals and consumers, the Company is advising immediate inspection of certain lots of Epinephrine Injection, Autoinjector 0.3mg devices from Amneal that have been dispensed since December 20, 2018, or that are currently part of inventory, for the presence of the yellow “stop collar.” A missing yellow “stop collar” may result in the administration of a double dose of epinephrine. Lots affected by this notice have been posted here.

To confirm the presence of the yellow “stop collar”, patients and healthcare professionals should:

1. Remove the autoinjector from the carrying case and place it on a flat surface.
2. Locate the edge of the label that states, “Peel here for further instructions.” Lift the label edge until the clear part of the autoinjector is visible.
3. Look for the yellow “stop collar” inside the clear part of the autoinjector. If the yellow “stop collar” is not visible inside the clear part of the autoinjector, 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 autoinjector.
4. If the yellow “stop collar” is present, then the product is safe to use, and no further action is necessary. Rewrap the label to its original position and place the autoinjector into the carrying case.

According to the FDA, the epinephrine autoinjectors are not being recalled. However, patients and healthcare professionals are urged to visually inspect the devices as stated above.

To report any device issues or to obtain a replacement, consumers should contact the Amneal Drug Safety Department at (877) 835-5472. Adverse reactions may be reported to the FDA’s MedWatch program.

For more information visit fda.gov.