ADRENACLICK

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

THE OFFICIAL GENERIC VERSION OF THE "ADRENACLICK" IT TOOK TIME TO RELEASE THE MEDICATION AND THE NEEDLE WAS BENT PROBLEM WITH A DEVICE [NEEDLE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL REGULATORY AUTHORITY REPORT CONCERNS OF ADVERSE EVENTS NEEDLE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 04-MAY-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM EMAIL CORRESPONDENCE FROM THE REGULATORY AUTHORITY, WITH REFERENCE NUMBER (AER# 26647931) CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTOINJECTOR. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTOINJECTOR 0.3 MILLIGRAM VIA SUBCUTANEOUS ROUTE (NDC: 0115-1694-49, BATCH NUMBER, EXPIRY DATE, DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE EPINEPHRINE AUTOINJECTOR (AMNEAL) THE OFFICIAL GENERIC VERSION OF THE ADRENACLICK, IT TOOK TIME TO RELEASE THE MEDICATION, AND THE NEEDLE WAS BENT, PROBLEM WITH A DEVICE WAS NOTED. LAST ACTION TAKEN WITH EPINEPHRINE AUTOINJECTOR IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTOINJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.