Description of Event or Problem · 0
THE PLUNGER HAS BEEN STOPPED AT MIDDLE OF THE INJECTION (NOT GOING FORWARDED NOR BACKWARD) [SYRINGE ISSUE]. HALF OF THE MEDICATION HAS BEEN INJECTED TO CONSUMER AND REMAIN HALF MEDICATION REMAINED AT INJECTION. [INCORRECT DOSE ADMINISTERED]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED IN A PATIENT (GENDER, AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 19-DEC-2023, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER HEALTHCARE PROFESSIONAL VIA A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. ON (B)(6) 2023, THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION/150/MG/ML (NDC: 70121-1467-2, LOT: 230083, EXPIRATION DATE: 30-APR-2024) FOR AN UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, HISTORICAL MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON AN UNKNOWN DATE, CONSUMER RECEIVED A COMPLETELY SEALED MEDICATION FROM HER PHARMACY. ON (B)(6) 2023, WHILE INJECTING MEDICATION TO CONSUMER THE REPORTER OBSERVED THAT THE PLUNGER HAS BEEN STOPPED AT MIDDLE OF THE INJECTION (NOT GOING FORWARDED NOR BACKWARD) AND HALF OF THE MEDICATION HAS BEEN INJECTED TO CONSUMER AND REMAIN HALF MEDICATION REMAINED AT INJECTION. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE IN RELATION TO SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. THIS CASE WAS CONSIDERED AS NON-SERIOUS. THE REPORTABILITY OF THIS CASE WAS PERIODIC. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 11-APR-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE INVESTIGATION AT THE MANUFACTURING SITE CONFIRMED COMPLIANCE OF PRIMARY PACKAGING MATERIALS AND IN-PROCESS CONTROLS, INCLUDING CCIT TESTING AND STOPPER POSITION VERIFICATION. COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, A GLOBAL REVIEW WITH AMNEAL AND CMO REVEALED THAT THE TRAYS USED FOR HOLDING PRE-FILLED SYRINGES MAY NOT PROVIDE SUFFICIENT SUPPORT, POTENTIALLY LEADING TO DAMAGE DURING TRANSPORTATION. THIS DESIGN ERROR IN THE CURRENT COMMERCIAL PFS HOLDING TRAYS, WHICH HAS NOT UNDERGONE A STRESS STUDY, IS CONSIDERED THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINTS. IN RESPONSE TO THESE FINDINGS, CAPA ACTION FA-CP-2024-042 HAS BEEN INITIATED TO PROPOSE A NEW TRAY DESIGN THAT IMPROVES SECONDARY PACKAGING AND SYRINGE PROTECTION, SUBJECTING IT TO A STRESS STUDY. AMNEAL REVIEWED PIL FOR HANDLING INSTRUCTIONS BUT DETERMINED CURRENT LABELING ALIGNS WITH RLD. STRENGTHENING PACKAGING CONFIGURATION WILL BE IMPLEMENTED TO ADDRESS THE ISSUE, WITH ONGOING MONITORING OF SUCH COMPLAINTS TO IDENTIFY NEED FOR ANY FURTHER ACTION. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE IN RELATION TO SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SYRINGE ISSUE AND INCORRECT DOSE ADMINISTERED WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. THIS CASE WAS CONSIDERED AS NON-SERIOUS. THE REPORTABILITY OF THIS CASE WAS PERIODIC. ON 15-JUL-2024, THIS CASE WAS REASSESSED AND UPGRADED TO SERIOUS, EXPEDITED FOR MALFUNCTION REPORT SUBMISSION. AMNEAL INITIATED AN INTERNAL INVESTIGATION (NOI REF # (B)(4)) FOR THIS LATE EXPEDITED CASE.