ADRENACLICK

Report

Report Number: 3002919960-2025-00044
Event Type: Malfunction
Date Received: November 28, 2025
Date of Event: November 14, 2025
Report Date: December 18, 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

Description of Event or Problem · 0

WHILE USING THE MEDICATION PATIENT OBSERVED THAT THE NEEDLE DID NOT COME OUT AND THE MEDICATION DID NOT WORK FOR HER [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 18-NOV-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 0115-1694-49, BATCH NO: G250602X, EXP DATE: 28-FEB-2027, AND SERIAL NO: (B)(6) VIA INTRAMUSCULAR ROUTE 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 WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION FROM PHARMACY. ON (B)(6) 2025, WHILE USING THE MEDICATION, THE PATIENT OBSERVED THAT THE NEEDLE DID NOT COME OUT AND THE MEDICATION DID NOT WORK FOR HER. THE PATIENT CONFIRMED THAT THE SECOND EPIPEN WORKED FINE FOR HER AND FURTHER REQUESTED REPLACEMENT FOR THE FIRST DEFECTIVE EPIPEN. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Description of Event or Problem · 0

WHILE USING THE MEDICATION PATIENT OBSERVED THAT THE NEEDLE DID NOT COME OUT AND THE MEDICATION DID NOT WORK FOR HER [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 0115-1694-49, BATCH NO: G250602X, EXP DATE: 28-FEB-2027, AND SERIAL NO: (B)(6) VIA INTRAMUSCULAR ROUTE 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 WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION FROM PHARMACY. ON (B)(6) 2025, WHILE USING THE MEDICATION, THE PATIENT OBSERVED THAT THE NEEDLE DID NOT COME OUT AND THE MEDICATION DID NOT WORK FOR HER. THE PATIENT CONFIRMED THAT THE SECOND EPIPEN WORKED FINE FOR HER AND FURTHER REQUESTED REPLACEMENT FOR THE FIRST DEFECTIVE EPIPEN. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 10-DEC-2025. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 18 NOVEMBER 2025, AMNEAL PRODUCT COMPLAINTS RECEIVED A REPORT FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT: G250602X (EXP. FEB 2027), DESCRIBING A ¿FAILURE TO FIRE,¿ SPECIFICALLY THAT THE NEEDLE DID NOT DEPLOY AND THE MEDICATION DID NOT WORK. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT WAS ASSIGNED TO THE SUB-TYPE FAILURE TO FIRE. AS THE ALLEGATION PERTAINED TO DEVICE ACTIVATION AND NOT TO DRUG PRODUCT MANUFACTURING, A CMO PFIZER INVESTIGATION WAS NOT WARRANTED; THE ISSUE FELL UNDER THE ASSEMBLY AND PACKAGING OPERATIONS PERFORMED AT THE CONTRACT PACKAGING ORGANIZATION (CPO), PHILLIPS (PMM). PHILLIPS CONDUCTED AN INVESTIGATION IN ACCORDANCE WITH SOP 8.2004 (COMPLAINTS/FEEDBACK). THE REPORTED FAILURE COULD NOT BE CONFIRMED. ALL IN-PROCESS INSPECTIONS FOR 200 UNITS AND ALL FINAL RELEASE TESTS ON 50 COMPOSITE UNITS MET SPECIFICATION WITH NO DISCREPANCIES, DEVIATIONS, OR ASSEMBLY DEFECTS THAT COULD EXPLAIN THE COMPLAINT. A RETAIN SAMPLE FROM LOT: G250602X WAS EVALUATED AND FOUND TO BE FULLY FUNCTIONAL WITH NO MECHANICAL, STRUCTURAL, OR OPERATIONAL ABNORMALITIES. THEREFORE, THE ALLEGED MALFUNCTION COULD NOT BE REPLICATED OR VERIFIED. A COMPLAINT HISTORY REVIEW FOUND NO OTHER COMPLAINTS FOR LOT: G250602X WITHIN THE PAST 24 MONTHS. ACROSS ALL LOTS RELEASED DURING THE SAME PERIOD (246 BATCHES / (B)(4) TWO-PACK DEVICES), THERE WERE 14 COMPLAINTS CATEGORIZED AS ¿FAILURE TO FIRE,¿ YIELDING A COMPLAINT FREQUENCY OF (B)(4). NONE OF THESE COMPLAINTS WERE CONFIRMED UPON EVALUATION, AND NO TREND, BATCH ASSOCIATION, OR RECURRING DEFECT WAS IDENTIFIED. REVIEW OF ANNUAL PRODUCT REPORTS AND STABILITY DATA REVEALED NO QUALITY CONCERNS OR EMERGING ISSUES ASSOCIATED WITH THIS COMPLAINT CATEGORY. THE INSTRUCTIONS FOR USE (IFU), DEVICE WRAP LABEL, AND CARTON LABELING WERE REVIEWED TO ASSESS CLARITY OF USE RELATED STEPS. THE IFU CONTAINS CLEAR, FDA-APPROVED INSTRUCTIONS AND PICTORIAL GUIDANCE ON DEVICE PREPARATION, ADMINISTRATION, NEEDLE DEPLOYMENT VERIFICATION, AND FAIL-SAFE STEPS. NO DEFICIENCIES OR OPPORTUNITIES FOR LABELLING IMPROVEMENT WERE IDENTIFIED. THE DEVICE ASSEMBLY, PACKAGING, AND LABELING PROCESSES WERE ALSO REINSPECTED, AND LOT RECONCILIATION WAS CONFIRMED AT 100% WITH NO QUALITY IMPACT. BECAUSE THE COMPLAINT SAMPLE WAS NOT RETURNED, AND ALL INVESTIGATIONAL DATA DEMONSTRATED COMPLIANT MANUFACTURING AND PROPER DEVICE FUNCTION, THE REPORTED FAILURE REMAINS UNCONFIRMED. NO LOT-RELATED, DESIGN RELATED, OR PROCESS-RELATED ROOT CAUSE COULD BE IDENTIFIED. USER ERROR REMAINS A POSSIBLE CONTRIBUTORY FACTOR BUT CANNOT BE VERIFIED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2229088	ADRENACLICK	TYPE 2	PQX	PHILLIPS-MEDISIZE LLC		G250602X

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Other