Looking for the yellow “stop collar” inside the clear part of the auto-injector. The FDA has issued an important alert to individuals with allergies and health-care professionals that some lots of Amneal and Impax Laboratories epinephrine auto-injectors (0.3 mg size) may be missing the yellow “stop collar.”. 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. Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise or … FDA is continuously monitoring adverse events reported with epinephrine auto-injector products. Estimated Resupply Dates Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation. June 03, 2020. Removing the auto-injector from the carrying case. See other news Epinephrine Auto-Injector 0.3mg Safety Advisory Read More. Impax Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals LLC, is providing important safety information concerning its Epinephrine Injection, USP Auto-Injector 0.3 mg. Impax is writing to inform you that some Epinephrine Injection, USP Auto-Injector 0.3 mg devices may not contain the yellow “stop collar” component (see pictures below). 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. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector. This is the generic version of the Adrenaclick auto-injector for sale at CVS pharmacies et al, but known under different names due to numerous acquisitions. Published: June 2, 2020. Re-wrap the label to its original position and place the auto-injector into the carrying case. Posted: August 17, 2020. [6/1/2020] 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. 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. FDA is aware of adverse event reports associated with EpiPen products. ... manufactured by Amneal… As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector. While some patients require a second dose of epinephrine, an epinephrine overdose has the potential to cause severe patient harm or death. It is vital for lifesaving products to work as designed in an emergency situation. 6/5/20 - Epinephrine (Impax/Amneal) MANUFACTURER RECALL Impax/Amneal is issuing the attached Product Safety Advisory for the above items/lots as some devices may not contain the yellow "stop collar" component, which could lead to a potential safety risk of deliverying an … FDA asks health care professionals and consumers to report any adverse events or quality problems to the FDA’s MedWatch program: An official website of the United States government, : What happens when you use an Amneal/Lineage (0.3 mg) epinephrine auto-injector device. Removing the auto-injector from the carrying case. FDA is alerting the public 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. Ranitidine Tablets, USP, 150 mg and … 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. Call the Amneal Drug Safety Department at 1-877-835-5472 if the yellow stop collar is missing and return defective devices for a replacement. AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager. An official website of the United States government, : Patients should contact their pharmacy regarding a replacement epinephrine auto-injector before returning the defective device to Amneal. Epinephrine injection, USP auto-injector contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Report adverse events or quality problems to the FDA’s MedWatch program. 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: Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day. Learn more about our Generic products: Before sharing sensitive information, make sure you're on a federal government site. Re-wrap the label to its original position and place the auto-injector into the carrying case. Two of them were Apotex and Amneal Pharmaceuticals, but the agency didn't name the others. The FDA asked five drugmakers to voluntarily recall their metformin products June 2. 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. 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. 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.