ADRENACLICK

Report

Report Number: 3002919960-2025-00045
Event Type: Malfunction
Date Received: November 28, 2025
Date of Event: November 10, 2025
Report Date: December 22, 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

UPON ASKING EXPIRATION DATE SHE PROVIDED AS MAY 2024 AND STATED THAT SHE REALIZED NOW THAT MEDICATION WAS EXPIRED [EXPIRED PRODUCT ADMINISTERED]. SHE WAS UNABLE TO INJECT EPIPEN AS THE MEDICATION WAS NOT COMING OUT OF THE NEEDLE [NEEDLE ISSUE]. WHEN SHE TRIED TO INJECT THE MEDICATION INTO HER LEG THE MEDICATION SPILLED OUT [DEVICE LEAKAGE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE IN A 45-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENTS EXPERIENCE WAS 45 YEARS. ON 14-NOV-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). ON (B)(6) 2025, THE PATIENT RECEIVED ADRENACLICK (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM VIA SUBCUTANEOUS ROUTE (FREQUENCY WAS NOT REPORTED) (NDC: 0115-1694-30, BATCH/LOT NUMBER: G220902X, EXPIRATION DATE: MAY-2024) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURES, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, HISTORICAL MEDICATION, MEDICAL HISTORY, ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED THE SEALED MEDICATION FROM HER PHARMACY AND ON (B)(6) 2025 WHILE USING SHE OBSERVED THAT SHE WAS UNABLE TO INJECT EPINEPHRINE AUTO-INJECTOR AS THE MEDICATION WAS NOT COMING OUT OF THE NEEDLE AND WHEN SHE TRIED TO INJECT THE MEDICATION INTO HER LEG THE MEDICATION SPILLED OUT. FURTHER, SHE STATED THAT SHE RECEIVED THE COMPLETE DOSE FROM THE SECOND EPINEPHRINE AUTO-INJECTOR WHICH WAS WORKING WELL. SHE PROVIDED EXPIRATION DATE OF THE PRODUCT AS MAY-2024 AND FURTHER SHE REALIZED THAT MEDICATION WAS EXPIRED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Description of Event or Problem · 0

UPON ASKING EXPIRATION DATE SHE PROVIDED AS MAY-2024 AND STATED THAT SHE REALIZED NOW THAT MEDICATION WAS EXPIRED [EXPIRED PRODUCT ADMINISTERED]. SHE WAS UNABLE TO INJECT EPIPEN AS THE MEDICATION WAS NOT COMING OUT OF THE NEEDLE [NEEDLE ISSUE]. WHEN SHE TRIED TO INJECT THE MEDICATION INTO HER LEG THE MEDICATION SPILLED OUT [DEVICE LEAKAGE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE IN A 45-YEAR-OLD FEMALE PATIENT (RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENTS EXPERIENCE WAS 45 YEARS. ON 14-NOV-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). ON (B)(6) 2025, THE PATIENT RECEIVED ADRENACLICK (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM VIA SUBCUTANEOUS ROUTE (FREQUENCY WAS NOT REPORTED) (NDC: 0115-1694-30, BATCH/LOT NUMBER: G220902X, EXPIRATION DATE: MAY-2024) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURES, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, HISTORICAL MEDICATION, MEDICAL HISTORY, ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED THE SEALED MEDICATION FROM HER PHARMACY AND ON 10-NOV-2025 WHILE USING SHE OBSERVED THAT SHE WAS UNABLE TO INJECT EPINEPHRINE AUTO-INJECTOR AS THE MEDICATION WAS NOT COMING OUT OF THE NEEDLE AND WHEN SHE TRIED TO INJECT THE MEDICATION INTO HER LEG THE MEDICATION SPILLED OUT. FURTHER, SHE STATED THAT SHE RECEIVED THE COMPLETE DOSE FROM THE SECOND EPINEPHRINE AUTO-INJECTOR WHICH WAS WORKING WELL. SHE PROVIDED EXPIRATION DATE OF THE PRODUCT AS MAY-2024 AND FURTHER SHE REALIZED THAT MEDICATION WAS EXPIRED. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 09-DEC-2025. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 17-NOV-2025, AMNEAL PRODUCT COMPLAINTS RECEIVED A NOTIFICATION FOR AN EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT: G220902X (EXP. MAY 2024), REPORTING THAT ¿MEDICATION WAS NOT COMING OUT OF THE NEEDLE AND SPILLED OUT DURING INJECTION.¿ THE COMPLAINT WAS CATEGORIZED AS A DEFECTIVE INJECTOR; HOWEVER, A PFIZER (CMO) INVESTIGATION WAS NOT REQUIRED, AS THE ISSUE PERTAINED TO ASSEMBLY AND FINAL PACKAGING PERFORMED BY PHILLIPS (CPO). COMPLAINT INTAKE CONFIRMED THAT THE REPORTER ATTEMPTED TO USE THE DEVICE ON 10-NOV-2025 AND ACKNOWLEDGED THE PRODUCT WAS EXPIRED FOR MORE THAN 17 MONTHS, STATING, ¿I REALIZE NOW THAT THE MEDICATION WAS EXPIRED.¿ PHILLIPS CONDUCTED AN INVESTIGATION AND CONFIRMED THAT LOT: G220902X MET ALL MANUFACTURING AND IN-PROCESS TESTING REQUIREMENTS. ALL 800 IN-PROCESS UNITS MET ACCEPTANCE CRITERIA, AND 80 COMPOSITE UNITS PASSED FINAL RELEASE TESTING. NO DEVIATIONS OR DISCREPANCIES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED ISSUE, AND THERE WAS NO CORRELATION BETWEEN MANUFACTURING OPERATIONS AND THE COMPLAINT. RETAIN EVALUATION WAS NOT PERFORMED BECAUSE THE LOT IS EXPIRED. THE RETURNED SAMPLE WAS RECEIVED IN A FIRED STATE AND CONFIRMED TO BE EXPIRED AT THE TIME OF USE. INSPECTION FOUND THE SHEATH, SHEATH REMOVER, AND INTERNAL COMPONENTS INTACT AND FUNCTIONING PROPERLY. THE FIRING MECHANISM SHOWED CHARACTERISTICS OF A FULLY ACTIVATED DEVICE, AND THE NEEDLE EXTENDED WITHIN SPECIFICATION, WITH VISIBLE SKIN TISSUE AND RESIDUAL SOLUTION, EVIDENCE OF PROPER FIRING AND DOSE DELIVERY. NO MECHANICAL DEFECTS WERE OBSERVED. THE REPORTED FAILURE MODE, LACK OF MEDICATION DELIVERY WITH SOLUTION SPILLING, COULD NOT BE CONFIRMED. ALL FINDINGS SUPPORT THAT THE DEVICE OPERATED AS DESIGNED. THE ROOT CAUSE IS DETERMINED TO BE USE OF AN EXPIRED PRODUCT, FALLING OUTSIDE VALIDATED PERFORMANCE CONDITIONS AND CONTRARY TO IFU INSTRUCTIONS, WHICH CLEARLY STATE THAT THE DEVICE MUST BE REPLACED BEFORE EXPIRATION. NO DEFICIENCIES IN LABELING OR INSTRUCTIONS FOR USE WERE IDENTIFIED, AND NO CHANGES ARE REQUIRED. NO DEVICE MALFUNCTION WAS FOUND. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS EXPIRED PRODUCT ADMINISTERED, NEEDLE ISSUE AND DEVICE LEAKAGE WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS 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
2265316	ADRENACLICK	TYPE 2	PQX	PHILLIPS-MEDISIZE LLC		G220902X

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR	Female	Other