In June 2020, the FDA issued an alert regarding inspection of select lots of Impax/Amneal’s epinephrine 0.3 mg autoinjector to ensure the presence of the yellow “stop collar.”28 This component helps to FDA: Amneal & Impax Laboratories epinephrine auto-injector device malfunctions can cause overdose. Epinephrine Auto-Injector Devices Safety Alert Date of Notice: 06/01/2020 Brief Description of Safety Alert 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. Amneal Pharmaceuticals, Inc. is a publicly listed company traded on the New York Stock Exchange (NYSE: AMRX). On May 4, 2018, Amneal Pharmaceuticals and Impax Laboratories combined under one corporate parent, and now operate as Amneal Pharmaceuticals. 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. Impax Laboratories is now part of Amneal Pharmaceuticals. Search Alerts/Recalls Impax has announced that some Epinephrine Injection, USP Auto-Injector 0.3mg devices may not contain the yellow “stop collar” component, one of several components which work together to assure proper dosing of the auto-injector. 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. The communication was not a device recall. Impax Laboratories is providing important safety information about sixty (60) lots of Epinephrine Injections. The recall was triggered by a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the FDA said Friday. If you have received Amneal or Impax’s 0.3mg epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by following the instructions below. were added to the package inserts of these products. Epinephrine injection, USP auto-injector contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise or … Reporter states she has two epi pens one with a missing stop collar and the other with a yellow collar above the window of the box. Recall letter received in the mail about missing yellow stop collar. Impax Labs issued an update on its Epinephrine Injection, USP Auto-Injector 0.15mg and 0.3mg, the generic of Adrenaclick, indicating the product is currently available. You can find photos to explain the steps in the letter sent to consumers . The Food and Drug Administration (FDA) is advising anyone with Amneal Pharmaceuticals LLC or Impax Laboratories epinephrine injection, USP auto-injector 0.3 mg device to make sure it has a yellow stop collar that controls the dose of medicine administered.