ADRENACLICK
Report
- Report Number
- 3002919960-2025-00040
- Event Type
- Malfunction
- Date Received
- October 20, 2025
- Date of Event
- September 27, 2025
- Report Date
- November 28, 2025
- Manufacturer
- PHILLIPS-MEDISIZE LLC
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MEDICATION DID NOT WORK PROPERLY/ ONE DOSE OF INJECTION WITHOUT ANY EFFECT [DRUG INEFFECTIVE], AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT [INCORRECT DOSE ADMINISTERED BY DEVICE], THE NEEDLE DID NOT DEPLOY PROPERLY [DEVICE DEPLOYMENT ISSUE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM INPATIENT PHARMACY SUPERVISOR (PHARMACIST) VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE). ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION 0.3 MG (NDC: 0115-1694-30) (BATCH NO, ROUTE, DOSE, AND FREQUENCY WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/DRINKING, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS NOT REPORTED. ON (B)(6) 2025, THE PATIENT WAS ADMINISTERED WITH A 0.3 MG STRENGTH OF EPINEPHRINE INJECTION; HOWEVER, IT WAS OBSERVED THAT THE MEDICATION DID NOT WORK PROPERLY, PATIENT RECEIVED ONE DOSE OF INJECTION WITHOUT ANY EFFECT. THE FIRST EPINEPHRINE AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT, WITH CONCERNS THAT THE NEEDLE DID NOT DEPLOY PROPERLY. A SECOND DOSE WAS GIVEN WITH APPROPRIATE EFFECT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 27-OCT-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT. BASED ON THE APR FINDINGS, MANUFACTURING CONTROLS, AND COMPLAINT HISTORY, THERE IS NO EVIDENCE OF A SYSTEMIC OR MANUFACTURING-RELATED ISSUE AT PMM. THE REPORTED COMPLAINT APPEARS TO BE ISOLATED, WITH NO CONFIRMED LINKAGE TO ASSEMBLY, PACKAGING, OR DEVICE PERFORMANCE TRENDS. HOWEVER, BECAUSE THE COMPLAINT SAMPLE WAS NOT RETURNED AND NO EVIDENCE WAS PROVIDED, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. POTENTIAL CONTRIBUTING FACTORS SUCH AS USER ERROR, DEVICE MALFUNCTION, OR IMPROPER HANDLING CANNOT BE RULED OUT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS AEPQC ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.
MEDICATION DID NOT WORK PROPERLY/ ONE DOSE OF INJECTION WITHOUT ANY EFFECT [DRUG INEFFECTIVE], AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT [INCORRECT DOSE ADMINISTERED BY DEVICE], THE NEEDLE DID NOT DEPLOY PROPERLY [DEVICE DEPLOYMENT ISSUE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 09-OCT-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM INPATIENT PHARMACY SUPERVISOR (PHARMACIST) VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE). ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION 0.3 MG (NDC: 0115-1694-30) (BATCH NO, ROUTE, DOSE, AND FREQUENCY WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/DRINKING, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS NOT REPORTED. ON (B)(6) 2025, THE PATIENT WAS ADMINISTERED WITH A 0.3 MG STRENGTH OF EPINEPHRINE INJECTION; HOWEVER, IT WAS OBSERVED THAT THE MEDICATION DID NOT WORK PROPERLY, PATIENT RECEIVED ONE DOSE OF INJECTION WITHOUT ANY EFFECT. THE FIRST EPINEPHRINE AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT, WITH CONCERNS THAT THE NEEDLE DID NOT DEPLOY PROPERLY. A SECOND DOSE WAS GIVEN WITH APPROPRIATE EFFECT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
MEDICATION DID NOT WORK PROPERLY/ ONE DOSE OF INJECTION WITHOUT ANY EFFECT [DRUG INEFFECTIVE]. AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT [INCORRECT DOSE ADMINISTERED BY DEVICE]. THE NEEDLE DID NOT DEPLOY PROPERLY [DEVICE DEPLOYMENT ISSUE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 09-OCT-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM INPATIENT PHARMACY SUPERVISOR (PHARMACIST) VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE). ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION 0.3 MG (NDC: 0115-1694-30) (BATCH NO, ROUTE, DOSE, AND FREQUENCY WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/DRINKING, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS NOT REPORTED. ON (B)(6) 2025, THE PATIENT WAS ADMINISTERED WITH A 0.3 MG STRENGTH OF EPINEPHRINE INJECTION; HOWEVER, IT WAS OBSERVED THAT THE MEDICATION DID NOT WORK PROPERLY, PATIENT RECEIVED ONE DOSE OF INJECTION WITHOUT ANY EFFECT. THE FIRST EPINEPHRINE AUTO-INJECTOR DID NOT ADMINISTER THE APPROPRIATE DOSE TO THE PATIENT, WITH CONCERNS THAT THE NEEDLE DID NOT DEPLOY PROPERLY. A SECOND DOSE WAS GIVEN WITH APPROPRIATE EFFECT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 27-OCT-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. BASED ON THE APR FINDINGS, MANUFACTURING CONTROLS, AND COMPLAINT HISTORY, THERE IS NO EVIDENCE OF A SYSTEMIC OR MANUFACTURING-RELATED ISSUE AT PMM. THE REPORTED COMPLAINT APPEARS TO BE ISOLATED, WITH NO CONFIRMED LINKAGE TO ASSEMBLY, PACKAGING, OR DEVICE PERFORMANCE TRENDS. HOWEVER, BECAUSE THE COMPLAINT SAMPLE WAS NOT RETURNED AND NO EVIDENCE WAS PROVIDED, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. POTENTIAL CONTRIBUTING FACTORS SUCH AS USER ERROR, DEVICE MALFUNCTION, OR IMPROPER HANDLING CANNOT BE RULED OUT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS AEPQC ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT. SIGNIFICANT FOLLOW UP (#2) INFORMATION WAS RECEIVED ON 04-NOV-2025. FOLLOW-UP INFORMATION (#2) WAS RECEIVED FROM PHARMACIST VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED: ADDED REPORTER PHONE NUMBER, ADDED PATIENT INITIALS AND DEMOGRAPHICS, ADDED CURRENT CONDITION, SUSPECT DRUG INDICATION AND NARRATIVE WAS UPDATED. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION 0.3 MG (NDC: 0115-1694-30) (BATCH NO, ROUTE, DOSE, AND FREQUENCY WERE NOT REPORTED) FOR ANAPHYLACTIC REACTION. CURRENT CONDITION INCLUDES ANAPHYLACTIC REACTION. ON (B)(6) 2025, EPINEPHRINE 0.3 MG AUTO-INJECTOR DID NOT WORK PROPERLY DURING USE FOR AN ANAPHYLACTIC REACTION. IT WAS FURTHER CONFIRMED THAT, THE PATIENT DID NOT FEEL THE NEEDLE PUNCTURE SKIN. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS DRUG INEFFECTIVE, INCORRECT DOSE ADMINISTERED BY DEVICE, AND DEVICE DEPLOYMENT ISSUE AS RELATED TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816912 | ADRENACLICK | TYPE 2 | PQX | PHILLIPS-MEDISIZE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | Other |