June 11, 2020 PR-M06-20-NI-015
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:
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.
FDA recommends that patients inspect their auto-injector devices as soon as possible and immediately contact the Amneal Drug Safety Department if they have questions about inspecting their auto-injector device, or if they’re unsure if the yellow “stop collar” is missing.
Pharmacists should inspect the products before dispensing them to patients to ensure the yellow “stop collar” is present. If the yellow “stop collar” is missing, pharmacists should not dispense the product and should contact Amneal.
The yellow “stop collar” is one of several components that work together to assure proper dosing of the auto-injector. While some patients require a second dose of epinephrine, an epinephrine overdose has the potential to cause severe patient harm or death. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.
FDA reminds patients and health care professionals that epinephrine auto-injectors are available through additional manufacturers.
FDA is notifying patients and caregivers that epinephrine auto-injectors are not being recalled. We urge patients and caregivers to use the epinephrine auto-injector they have on hand and be aware of the potential issues outlined in the statement above.
FDA is continuously monitoring adverse events reported with epinephrine auto-injector products. FDA asks health care professionals and consumers to report any adverse events or quality problems to the FDA’s MedWatch program:
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