AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager
ISSUE: 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. 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.
BACKGROUND: Epinephrine Auto-Injector Devices are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.
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:
- Removing the auto-injector from the carrying case.
- Placing the auto-injector on a flat surface.
- 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.
- 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.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.
Epinephrine auto-injectors are not being recalled. FDA urges patients to use the epinephrine auto-injector they have on hand and be aware of the potential issues outlined in the statement above.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form or submit by fax to 1-800-FDA-0178
[06/01/2020 - CDER Alert - FDA]