MAGNESIUM SULFATE

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10

Description of Event or Problem

INADVERTENT ADMINISTRATION OF TRANEXAMIC [WRONG PRODUCT ADMINISTERED]. MEDICATION MISLABELED [PRODUCT LABEL ON WRONG PRODUCT]. PAIN AND SUFFERING [PAIN]. EMOTIONAL DISTRESS [EMOTIONAL DISTRESS]. LOSS OF QUALITY OF LIFE RESULTING FROM THE PHYSIOLOGICAL TRAUMA [QUALITY OF LIFE DECREASED]. INABILITY TO PERFORM WORK DUTIES [IMPAIRED WORK ABILITY]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS WRONG PRODUCT ADMINISTERED, PRODUCT LABEL ON WRONG PRODUCT, PAIN, EMOTIONAL DISTRESS, QUALITY OF LIFE DECREASED AND IMPAIRED WORK ABILITY IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MAGNESIUM SULFATE AND TRANEXAMIC ACID. THE PATIENT WAS BEING TREATED WITH MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML (BATCH NO: AH250162) (DOSE, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. THE PATIENT WAS INADVERTENTLY ADMINISTERED TRANEXAMIC ACID (DOSE, STRENGTH, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CO-SUSPECT, CONCOMITANT MEDICATION, CONCURRENT CONDITION, MEDICAL HISTORY, HISTORICAL MEDICATION, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE PATIENT WAS ADMINISTERED MEDICATION FROM THIS AFFECTED (RECALLED) LOT DURING THE DESIGNATED DISTRIBUTION WINDOW AND SUBSEQUENTLY SUFFERED SIGNIFICANT MEDICAL COMPLICATIONS CONSISTENT WITH THE INADVERTENT ADMINISTRATION OF TRANEXAMIC ACID INSTEAD OF MAGNESIUM SULFATE DUE TO PRODUCT MIX UP (POUCHES LABELED AS MAGNESIUM SULFATE CONTAINED TRANEXAMIC ACID). AS A RESULT, THE PATIENT EXPERIENCED PAIN AND SUFFERING, EMOTIONAL DISTRESS, AND LOSS OF QUALITY OF LIFE RESULTING FROM THE PHYSIOLOGICAL TRAUMA OF RECEIVING THE INCORRECT MEDICATION. FINANCIAL IMPACT DUE TO RECOVERY TIME AND INABILITY TO PERFORM WORK DUTIES. LAST ACTION TAKEN WITH MAGNESIUM SULFATE AND TRANEXAMIC ACID IN RELATION TO WRONG PRODUCT ADMINISTERED, PRODUCT LABEL ON WRONG PRODUCT, PAIN, EMOTIONAL DISTRESS, QUALITY OF LIFE DECREASED AND IMPAIRED WORK ABILITY WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF WRONG PRODUCT ADMINISTERED, PRODUCT LABEL ON WRONG PRODUCT, PAIN, EMOTIONAL DISTRESS, QUALITY OF LIFE DECREASED AND IMPAIRED WORK ABILITY WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS PAIN, EMOTIONAL DISTRESS, QUALITY OF LIFE DECREASED, IMPAIRED WORK ABILITY AS RELATED TO TRANEXAMIC ACID. WHILE REPORTER DID NOT PROVIDE THE CAUSALITY OF WRONG PRODUCT ADMINISTERED AND PRODUCT LABEL ON WRONG PRODUCT WITH TRANEXAMIC ACID. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF WRONG PRODUCT ADMINISTERED, PRODUCT LABEL ON WRONG PRODUCT, PAIN, EMOTIONAL DISTRESS, QUALITY OF LIFE DECREASED AND IMPAIRED WORK ABILITY WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.