BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDROXYPROGESTERONE ACETATE

    MDR report key: 23143065 · Received September 25, 2025

    Report

    Report Number
    3014424887-2025-00017
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Report Date
    November 6, 2025
    Manufacturer
    LABORATORIES FARMALAN S.A.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE-DOSE SYRINGE [PRODUCT DELIVERY MECHANISM ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS ADVERSE EVENTS OF PRODUCT DELIVERY MECHANISM ISSUE 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 EXPERIENCE WERE NOT REPORTED. ON 18-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM MEDICAL ASSISTANT VIA A TELEPHONIC CALL CONCERNING ABOVE MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MEDROXYPROGESTERONE ACETATE. THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE 150/MG/ML (NDC: 70121-1480-1, BATCH/LOT: 240310, EXPIRATION DATE: NOV-2026 AND SERIAL NUMBER: (B)(6)) (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKER, ALCOHOLIC, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. ON (B)(6) 2025, THE PHARMACY DISPENSED THE MEDICATION TO THE PATIENT. ON (B)(6) 2025, THE PATIENT REPORTED, WHEN THE NURSE WAS ABOUT TO ADMINISTER THE MEDICATION, THEY OBSERVED THAT THE MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE-DOSE SYRINGE. FURTHER IT WAS REPORTED THAT THE MEDICATION WAS STORED AT ROOM TEMPERATURE (70 DEGREE F) AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WITH MEDROXYPROGESTERONE ACETATE. THE REPORTABILITY OF THIS CASE WAS SERIOUS. THIS CASE WAS CONSIDERED EXPEDITED.

    Description of Event or Problem · 0

    MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE-DOSE SYRINGE [PRODUCT DELIVERY MECHANISM ISSUE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS ADVERSE EVENTS OF PRODUCT DELIVERY MECHANISM ISSUE 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 EXPERIENCE WERE NOT REPORTED. ON 18-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM MEDICAL ASSISTANT VIA A TELEPHONIC CALL CONCERNING ABOVE MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MEDROXYPROGESTERONE ACETATE. THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE 150/MG/ML (NDC: 70121-1480-1, BATCH/LOT: 240310, EXPIRATION DATE: NOV-2026 AND SERIAL NUMBER: (B)(6) (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKER, ALCOHOLIC, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. ON 04-SEP-2025, THE PHARMACY DISPENSED THE MEDICATION TO THE PATIENT. ON (B)(6) 2025, THE PATIENT REPORTED, WHEN THE NURSE WAS ABOUT TO ADMINISTER THE MEDICATION, THEY OBSERVED THAT THE MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE-DOSE SYRINGE. FURTHER IT WAS REPORTED THAT THE MEDICATION WAS STORED AT ROOM TEMPERATURE (70 DEGREE F) AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WITH MEDROXYPROGESTERONE ACETATE. THE REPORTABILITY OF THIS CASE WAS SERIOUS. THIS CASE WAS CONSIDERED EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 29-OCT-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. IT HAS NOT BEEN DETECTED ANY POTENTIAL ROOT CAUSE RELATED WITH THE MANUFACTURING PROCESS PERFORMED IN FARMALAN PREMISES. DURING THE INVESTIGATION IT IS CONFIRMED THAT: ASEPTIC FILLING AND VISUAL INSPECTION PROCESSES OF BATCH 240310 WERE CONFORMING. NO RECORD FOUND IN RELATION TO THE PROBLEM STATEMENT. DOSE CONTROL IPCS REVIEWED AND CONFIRMED TO BE COMPLIANT. THE RELATED MATERIAL BATCHES USED ON THE MANUFACTURING OF BATCH ARE COMPLIANT AND HAVE BEEN USED FOR THE MANUFACTURE OF OTHER RELEASED FINAL UNITS. RETENTION AND REFERENCE SAMPLES ARE COMPLIANT. BATCH RECORD DOCUMENTATION WITH NO ISSUES. INSPECTION OF PARTICLES AND VISIBLE DEFECTS WITH NO ANOMALIES. STABILITY RESULTS REVIEWED WITH NO DETECTED ISSUES. QC RELEASE TESTING (AND SPECIFICALLY CCIT, CONTAINER CONTENT, GLIDING FORCE AND BREAK LOOSE) REVIEWED WITH COMPLIANT RESULTS. APR REVIEWED WITH NO ISSUES. AFTER FINISHING INVESTIGATION, IT WAS CONCLUDED THAT ISSUE IS NOT LIKELY TO HAVE OCCURRED DURING MANUFACTURING PROCESS PERFORMED IN FARMALAN PREMISES. BEARING IN MIND ALL THE PREVIOUS INFORMATION, BATCH 240310 MAINTAINS ITS STATUS AS CONFORMING AS IT HAS NO IMPACT ON PRODUCT QUALITY, EFFICACY OR SAFETY. THE UNITS THAT ARE IN THE MARKET AND THAT HAVE ALREADY BEEN RELEASED ARE NOT IMPACTED FOR THIS COMPLAINT. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WITH MEDROXYPROGESTERONE ACETATE. THE REPORTABILITY OF THIS CASE WAS SERIOUS. THIS CASE WAS CONSIDERED 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
    2394291 MEDROXYPROGESTERONE ACETATE TYPE 2 FMF LABORATORIES FARMALAN S.A. 240310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other