ADRENACLICK

Description of Event or Problem

THE MEDICATION DID NOT DELIVER TO PATIENT AND THE NEEDLE DID NOT RETRACT AS IT SHOULD [PRODUCT DOSE OMISSION ISSUE]. THE MEDICATION DID NOT DELIVER TO PATIENT AND THE NEEDLE DID NOT RETRACT AS IT SHOULD [DEVICE DELIVERY SYSTEM ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF EVENTS PRODUCT DOSE OMISSION ISSUE AND DEVICE DELIVERY SYSTEM ISSUE IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. ON (B)(6) 2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PHARMACY TECHNICIAN VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE EPINEPHRINE INJECTION (AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (LOT G240102X, EXP: 31-JUL-2027) (FREQUENCY AND THERAPY DATES NOT REPORTED) VIA SUBCUTANEOUS ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, HISTORICAL DRUG AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2026, THE NURSE ATTEMPTED TO INJECT THE MEDICATION, AND THE MEDICATION DID NOT DELIVER TO THE PATIENT. NURSE REPORTED IT TO PHARMACY IMMEDIATELY. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DOSE OMISSION ISSUE AND DEVICE DELIVERY SYSTEM ISSUE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS AND PRODUCT DOSE OMISSION ISSUE AND DEVICE DELIVERY SYSTEM ISSUE WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF PRODUCT DOSE OMISSION ISSUE AND DEVICE DELIVERY SYSTEM ISSUE WITH RESPECT TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.