BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDROXYPROGESTERONE ACETATE

    MDR report key: 23120214 · Received September 23, 2025

    Report

    Report Number
    3014424887-2025-00016
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 28, 2025
    Manufacturer
    LABORATORIES FARMALAN S.A.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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 08-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY MANAGER 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, BATCH NO, EXPIRATION DATE, SERIAL NUMBER, DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE 150/MG/ML (NDC: (B)(4), BATCH NO: 240236, EXPIRATION DATE: MAY-2026) (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, PHARMACY RECEIVED SEALED MEDICATION FROM THE WHOLESALER. ON (B)(6) 2025, THE PHARMACY DISPENSED THE MEDICATION TO THE PATIENT. ON (B)(6) 2025, WHEN THE NURSE WAS ABOUT TO ADMINISTER THE MEDICATION, THEY OBSERVED THAT THE MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE DOSE SYRINGE. THE MEDICATION HAD BEEN STORED PROPERLY AT ROOM TEMPERATURE (70°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. THIS CASE WAS CONSIDERED EXPEDITED. THE REPORTABILITY OF THIS CASE WAS SERIOUS. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 25-NOV-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. DURING THE INVESTIGATION IT IS CONFIRMED THAT: ASEPTIC FILLING AND VISUAL INSPECTION PROCESSES OF BATCH 240230 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. DESCRIPTION OF DEFECT: THE DEFECT CONSISTS OF A LACK OF MTERNAL COMMUNICATION BETWEEN THE BARREL AND THE TIP OF THE SYRINGE, RESULTING IN THE IMPOSSIBILITY OF ADMINISTERING THE MEDICATION. ALTHOUGH THE SYRINGE MAY APPEAR EXTERNALLY INTACT, INTERNAL OBSTRUCTION PREVENTS ANY PRODUCT FROM BEING DELIVERED. SPECIFIC CASE ASSESSMENT: IN THE REPORTED COMPLAINT, THE DEFECT WAS IDENTIFIED BY THE PATIENT PRIOR TO USE, NO ATTEMPT TO ADMINISTER THE MEDICATION WAS MADE. AND A REPLACEMENT WAS REQUESTED. THE DEFECTIVE SAMPLE REMAINS AVAILABLE FOR EVALUATION. THE PATIENT IMPACT IS: NONE. NO EXPOSURE OCCURRED. AND NO ADVERSE EVENT WAS REPORTED. GENERAL RISK ASSESSMENT: THIS TYPE OF DEFECT IS CLASSIFIED AS A CRITICAL DEVICE DEFECT DUE TO ITS DIRECT IMPACT ON THE FUNCTIONALITY OF THE DELIVERY SYSTEM. HOWEVER, SINCE THE DEFECT CAN BE EASILY DETECTED PRIOR TO ADMINISTRATION. THE MEDICATION CANNOT BE DELIVERED, NO EXPOSURE OCCURS AND HENCE, THE PATIENT IMPACT IS NULL. THIS THE FIRST COMPLAINT REPORTED WITH THIS DESCRIPTION. THE ISSUE HAS NOT BEEN IDENTIFIED DURING FCS, AQLS, RETAIN/REFERENCE SAMPLE INSPECTIONS, OR 100% VISUAL INSPECTIONS. CONSIDERING ALL RELEVANT INSPECTIONS PERFORMED ON THE SYRINGES. THIS TYPE OF DEFECT HAS NOT PREVIOUSLY BEEN DETECTED AND APPEARS TO BE MINIMAL IN OCCURRENCE AND US SUCH, THE CLASSIFICATION OF THE DEFECT IS CONSIDERED NEGLIGIBLE. AFTER FINISHING THE INVESTIGATION, IT HAS NOT BEEN DETECTED ANY POTENTIAL ROOT CAUSE RELATED WITH THE MANUFACTURING PROCESS PERFORMED IN FARMALAN PREMISES. HOWEVER, IT WAS IDENTIFIED THAT ISSUE IS RELATED TO THE SYRINGE SUPPLIER MANUFACTURING PROCESSES. CONSIDERING THIS, SYRINGE SUPPLIER WAS NOTIFIED OF THE REPORTED ISSUE WHEN CASE (B)(4) WAS RECEIVED AND A FORMAL COMPLAINT WAS OPENED TO SUPPLIER WITH CODE (B)(4). SUPPLIER CONCLUDED IN THEIR INVESTIGATION THAT THE LACK OF A FULLY AUTOMATED, CONTINUOUS INSPECTION LEFT A POTENTIAL BLIND SPOT IN THE SYSTEM. THIS MEANT THAT AN ISOLATED DEFECT, SUCH AS A MISSING OR INCOMPLETELY FORMED CHANNEL, COULD GO UNDETECTED IF DID NOT COINCIDE WITH A MANUAL INSPECTION SAMPLE. RECOGNIZING THIS VULNERABILITY, THE SUPPLIER HAS SINCE UPGRADED ALL PRODUCTION LINES TO FULLY AUTOMATED SYSTEMS WITH 100% CAMERA INSPECTION ON ALL CRITICAL PARAMETERS, INCLUDING TIP-CHANNEL FORMATION. FURTHERMORE, AN ADDITIONAL INSPECTION STATION (STATION 1 3) HAS BEEN IMPLEMENTED SPECIFICALLY TO DETECT INTERNAL BLOCKAGES OR MALFORMATIONS DURING PRODUCTION, THESE IMPROVEMENTS HAVE EFFECTIVELY CLOSED THE BLIND SPOT AND ARE EXPECTED TO ELIMINATE THE RECURRENCE OF THIS TYPE OF DEFECT IN FUTURE BATCHES. HENCE, NO CAPA IS PROPOSED AS THE ISSUE IS ALREADY ASSESSED. 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.

    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 08-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY MANAGER 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, BATCH NO, EXPIRATION DATE, SERIAL NUMBER, DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON 08-SEP-2025, THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE 150/MG/ML (NDC: 70121-1480-1, BATCH NO: 240236, EXPIRATION DATE: MAY-2026) (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, PHARMACY RECEIVED SEALED MEDICATION FROM THE WHOLESALER. ON 05-SEP-2025, THE PHARMACY DISPENSED THE MEDICATION TO THE PATIENT. ON (B)(6) 2025, WHEN THE NURSE WAS ABOUT TO ADMINISTER THE MEDICATION, THEY OBSERVED THAT THE MEDICATION WAS NOT COMING OUT OF THE PREFILLED SINGLE DOSE SYRINGE. THE MEDICATION HAD BEEN STORED PROPERLY AT ROOM TEMPERATURE (70°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. THIS CASE WAS CONSIDERED EXPEDITED. THE REPORTABILITY OF THIS CASE WAS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340153 MEDROXYPROGESTERONE ACETATE TYPE 2 FMF LABORATORIES FARMALAN S.A. 240236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other