Description of Event or Problem · 0
ONLY HALF OF MEDICATION ONLY WENT INTO PATIENT BODY [UNDERDOSE]. REMAINING HALF WAS LEAKED OUT [SYRINGE ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS ADVERSE EVENTS OF UNDERDOSE AND SYRINGE ISSUE IN A FEMALE PATIENT (AGE AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM MEDICAL ASSISTANT VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MEDROXYPROGESTERONE ACETATE. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE 150 MG/ML (NDC: 70121-1480-01, BATCH NO: 230173, EXPIRATION DATE: SEP-2025, S/N: (B)(6)) (DOSE, FREQUENCY AND THERAPY DATE 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 10-APR-2024, CONSUMER RECEIVED SEALED MEDICATION FROM PHARMACY AND WHEN NURSE INJECTING THE MEDICATION TO PATIENT, THEY NOTICED THAT ONLY HALF OF MEDICATION ONLY WENT INTO PATIENT BODY AND REMAINING HALF WAS LEAKED OUT AND MEDICATION TOTALLY LEAKED ON NURSE SHIRT AND FLOOR. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE TO UNDERDOSE AND SYRINGE ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF UNDERDOSE AND SYRINGE ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS OF UNDERDOSE AND SYRINGE ISSUE AS NOT REPORTED. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 05-JUL-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE REPORTED DEFECT WITH MEDROXYPROGESTERONE SYRINGES IS UNLIKELY TO HAVE ORIGINATED DURING THE MANUFACTURING PROCESS AT FARMALAN. ALL PRIMARY PACKAGING MATERIALS WERE REVIEWED, TESTED, AND FOUND TO BE WITHIN SPECIFICATIONS. THE PACKAGING PROCESS CONTROLS WERE PERFORMED WITH CONFORMING RESULTS, AND TESTS PERFORMED WITH ASSEMBLED SYRINGE ALONG WITH NEEDLE MEASURING BREAK LOOSE FORCE AND GLIDING FORCE WERE COMPLIANT. NO RELATED INCIDENTS WERE DETECTED DURING BATCH RECORD REVIEW, AND RETENTION SAMPLES WERE FOUND TO BE COMPLIANT. CONTROL SYSTEMS VERIFICATION IS ROUTINELY PERFORMED THROUGHOUT THE PACKAGING PROCESS. CONSIDERING ALL THIS, THE ROOT CAUSE IS LIKELY RELATED TO THE ADMINISTRATION PROCESS, POSSIBLY DUE TO ADMINISTERING THE MEDICATION TOO QUICKLY, LEADING TO INCREASED PRESSURE INSIDE THE SYRINGE AND CAUSING LEAKAGE AT THE NEEDLE ATTACHMENT POINT. ADDITIONALLY, DUE TO A CONCERNING TREND OF COMPLAINTS REGARDING MEDROXYPROGESTERONE FOR INJECTION 150MG/ML PFS, A FIELD ALERT REPORT HAS BEEN FILED WITH THE FDA. A QUALITY RISK ASSESSMENT WAS PERFORMED TO EVALUATE ASSOCIATED RISKS RELATED TO PATIENT SAFETY, PRODUCT EFFICACY, AND MARKET COMPLIANCE. AN ADDENDUM TO THIS INVESTIGATION REPORT WAS CONDUCTED TO INCORPORATE THE QUALITY RISK MANAGEMENT (QRM) OUTCOME. BASED ON THE RISK ASSESSMENT, IT WAS OBSERVED THAT THE INCIDENT RATES OF COMPLAINTS ARE VERY LOW. THESE COMPLAINTS ARE ASSESSED AS LOW RISK OVERALL, CONSIDERING THAT ALL DEFECTIVE UNITS WERE IDENTIFIED PRIOR TO USE AND REPLACED WITH NEW UNITS, THUS HAVING NO IMPACT ON PATIENT SAFETY OR PRODUCT EFFICACY. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE TO UNDERDOSE AND SYRINGE ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF UNDERDOSE AND SYRINGE ISSUE WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS OF UNDERDOSE AND SYRINGE ISSUE AS NOT REPORTED. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. AMNEAL INITIATED AN INTERNAL INVESTIGATION (NOI REF # (B)(4)) FOR THIS LATE EXPEDITED CASE.