MAGNESIUM SULFATE

Additional Manufacturer Narrative

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Description of Event or Problem

MEDICATION MISLABELED [PRODUCT LABEL ON WRONG PRODUCT] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 28-FEB-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A NON-HEALTHCARE PROFESSIONAL VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MAGNESIUM SULFATE IN WATER FOR INJECTION USP. ADDITIONAL SIGNIFICANT INFORMATION (#1) AND (#2) WAS RECEIVED ON 02-MAR-2026 AND 03-MAR-2026 FROM NON-HEALTHCARE PROFESSIONAL VIA AN EMAIL. NEW INFORMATION INCLUDED REPORTER¿S ADDRESS AND CONTACT DETAILS AND NARRATIVE WAS UPDATED ACCORDINGLY. THE PATIENT WAS BEING TREATED WITH MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML (40 MG/ML) (NDC: 70121-1720-1, BATCH NO: AH250162, EXP DATE:31-AUG-2027) (DOSE, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. 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 MAGNESIUM SULFATE WAS OBTAINED FROM PHARMACY AND RECEIVED THE 24 PACK AROUND 30-DEC-2025. THEY HAVE ALSO JUST PURCHASED THE MAGNESIUM SULFATE AGAIN ON 27-FEB-2026. AFTER SCANNING THE PACKAGING, THEY OPENED THE BAG AND DISCOVERED THAT THE BAG WAS TRANEXAMIC ACID (TXA) INSTEAD OF MAGNESIUM SULFATE. THE TXA BAG LOOKS ALMOST IDENTICAL TO THE MAGNESIUM SULFATE BAG. THEY HAVE TOTAL 12 PACKS WITH NDC 70121172003, LOT AH250162, EXPIRATION 31-AUG-2027 AND TRANEXAMIC ACID 1G/100 ML RTU NDC 80830232902, LOT AH250139, EXPIRATION 31-AUG-2027 AND THEY HAVEN¿T BOUGHT THE TXA NDC SINCE AUGUST. LAST ACTION TAKEN WITH MAGNESIUM SULFATE IN RELATION TO PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

MEDICATION MISLABELED [PRODUCT LABEL ON WRONG PRODUCT] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 28-FEB-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A NON-HEALTHCARE PROFESSIONAL VIA AN EMAIL CONCERNING ABOVE-MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MAGNESIUM SULFATE IN WATER FOR INJECTION USP. ADDITIONAL SIGNIFICANT INFORMATION (#1) AND (#2) WAS RECEIVED ON 02-MAR-2026 AND 03-MAR-2026 FROM NON-HEALTHCARE PROFESSIONAL VIA AN EMAIL. NEW INFORMATION INCLUDED REPORTER¿S ADDRESS AND CONTACT DETAILS AND NARRATIVE WAS UPDATED ACCORDINGLY. THE PATIENT WAS BEING TREATED WITH MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML (40 MG/ML) (NDC: 70121-1720-1, BATCH NO: AH250162, EXP DATE:31-AUG-2027) (DOSE, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. 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 MAGNESIUM SULFATE WAS OBTAINED FROM PHARMACY AND RECEIVED THE 24 PACK AROUND 30-DEC-2025. THEY HAVE ALSO JUST PURCHASED THE MAGNESIUM SULFATE AGAIN ON 27-FEB-2026. AFTER SCANNING THE PACKAGING, THEY OPENED THE BAG AND DISCOVERED THAT THE BAG WAS TRANEXAMIC ACID (TXA) INSTEAD OF MAGNESIUM SULFATE. THE TXA BAG LOOKS ALMOST IDENTICAL TO THE MAGNESIUM SULFATE BAG. THEY HAVE TOTAL 12 PACKS WITH NDC 70121172003, LOT AH250162, EXPIRATION 31-AUG-2027 AND TRANEXAMIC ACID 1G/100 ML RTU NDC 80830232902, LOT AH250139, EXPIRATION 31-AUG-2027 AND THEY HAVEN¿T BOUGHT THE TXA NDC SINCE AUGUST. LAST ACTION TAKEN WITH MAGNESIUM SULFATE IN RELATION TO PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#3) INFORMATION RECEIVED ON 16-APR-2026. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. A COMPLAINT WAS RECEIVED FOR THE PRODUCT MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML (NDC 70121-1720-3), BATCH NO. AH250162, STATING ¿MEDICATION MISLABELLED¿ (COMPLAINT NO. (B)(4)). THE COMPLAINT WAS REPORTED BY RONALD REAGAN UCLA MEDICAL CENTER, USA. THE COMPLAINANT REPORTED THAT UPON OPENING THE FOIL POUCH, THE INNER IV BAG WAS LABELED AS ¿TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION.¿ A FIELD ALERT REPORT (FAR) WAS INITIATED ON 03-MAR-2026 WITH THE AGENCY REGARDING THE COMPLAINT. BASED ON THE REVIEW OF THE BATCH MANUFACTURING PROCESS, EXISTING CONTROL MEASURES, BATCH RECORDS OF THE COMPLAINT BATCH, OPERATIONAL SOPS, AND FINISHED PRODUCT ANALYTICAL RESULTS, NO DISCREPANCY WAS OBSERVED THAT COULD EXPLAIN THE REPORTED COMPLAINT. VERIFICATION OF RETAINED SAMPLES AND DISPATCHED UNITS OF THE COMPLAINT BATCH UNDER THE CONTROL OF AMNEAL, ALONG WITH ADDITIONAL VERIFICATION AT THE COMPLAINANT¿S END, REVEALED NO SIMILAR OBSERVATIONS CONSISTENT WITH THE COMPLAINT DESCRIPTION. A HEALTH HAZARD ASSESSMENT WAS PERFORMED BASED ON THE REPORTED COMPLAINT. CONSIDERING THE VERIFIED UNITS, ESTABLISHED CONTROL MEASURES PRIOR TO ADMINISTRATION, AND THE ABSENCE OF ADVERSE EVENT REPORTS TO DATE, THE IDENTIFIED RISK WAS DETERMINED TO BE LOW. A VOLUNTARY RECALL OF MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML, BATCH NO. AH250162, WAS INITIATED ON 18-MAR-2026. BASED ON A COMPREHENSIVE WALKTHROUGH AND DETAILED VERIFICATION OF MANUFACTURING AND PACKAGING OPERATIONS, IT WAS INFERRED THAT THE MIX-UP MOST LIKELY OCCURRED DUE TO INADEQUATE CONTROL AT THE COLLECTION STAGE FOLLOWING THE COMPLETION OF TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION 1000 MG/100 ML, BATCH NO. AH250139. THE OMISSION OF CRATE CLEANING, COUPLED WITH THE ABSENCE OF PHYSICAL VERIFICATION OF REJECTED UNITS, CREATED A SITUATION IN WHICH A FILLED BAG FROM THE PREVIOUS BATCH REMAINED UNATTENDED IN A COLLECTION CRATE. AS MAGNESIUM SULFATE IN WATER FOR INJECTION 4 G/100 ML, BATCH NO. AH250162, WAS PROCESSED SUBSEQUENTLY USING THE SAME CRATES, THE UNATTENDED BAG WAS INADVERTENTLY CARRIED OVER AND PROGRESSED THROUGH DOWNSTREAM OPERATIONS. DUE TO IDENTICAL BAG SIZE, FILL VOLUME, LABEL COLOR, AND PROCESSING PARAMETERS, BOTH PRODUCTS APPEARED SIMILAR AT SUBSEQUENT STAGES, PREVENTING DETECTION DURING RECONCILIATION AND INSPECTION ACTIVITIES. AS BOTH MAGNESIUM SULFATE INJECTION 4 G/100 ML, BATCH NO. AH250162, AND TRANEXAMIC ACID INJECTION 1000 MG/100 ML, BATCH NO. AH250139, ARE MARKETED PRODUCTS AND NO SIMILAR OBSERVATIONS WERE IDENTIFIED DURING THE REVIEW OF BATCH UNITS, THE POSSIBILITY OF A MIX-UP OCCURRING AT THE HOSPITAL OR END-USER LEVEL CANNOT BE COMPLETELY RULED OUT. A HISTORICAL REVIEW OF PRODUCT COMPLAINTS OVER THE PAST TWO YEARS (PRIOR TO 03-MAR-2026) INDICATED NO PREVIOUS COMPLAINTS RELATED TO PRODUCT MISLABELING. THE INVESTIGATION CONCLUDES THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS INADEQUATE CLEANING OF THE COLLECTION CRATE DURING LINE CLEARANCE, RESULTING IN ONE BAG FROM THE PREVIOUS BATCH REMAINING IN THE CRATE AND BEING OVERLOOKED DURING CLEARANCE. CONSEQUENTLY, THIS STRAY UNIT REMAINED UNATTENDED AND WAS INADVERTENTLY MIXED WITH THE NEXT BATCH, LEADING TO UNINTENDED CARRYOVER. THIS WAS NOT DETECTED DURING RECONCILIATION BECAUSE REJECTED BAGS WERE NOT PHYSICALLY VERIFIED, AND RECONCILIATION RELIED SOLELY ON MACHINE COUNTER AND CHECKWEIGHER COUNTS. FURTHERMORE, DUE TO IDENTICAL BAG SIZE, FILL VOLUME, LABEL APPEARANCE, AND COMPARABLE PROCESSING PARAMETERS, THE STRAY UNIT COULD NOT BE VISUALLY DIFFERENTIATED AND THEREFORE REMAINED UNDETECTED DURING SUBSEQUENT PROCESSING STAGES. ADDITIONALLY, THE POSSIBILITY OF A MIX-UP OCCURRING AT THE HOSPITAL OR END-USER LEVEL CANNOT BE COMPLETELY EXCLUDED. BASED ON AN ASSESSMENT OF PRODUCTS MANUFACTURED OVER THE PAST TWO YEARS ON BAG LINE (LINE-2), INCLUDING A REVIEW OF SEQUENTIAL MANUFACTURING OF PRODUCTS WITH THE SAME FILL VOLUME, NO EVIDENCE OF RECURRENCE WAS IDENTIFIED, INDICATING THAT THE EVENT IS ISOLATED. BATCH NOS. AH250139 AND AH250162 WERE RELEASED IN COMPLIANCE WITH SOP NO. AC-QA-002, ¿REVIEW OF BATCH RECORD, FINISHED GOODS TRANSFER, AND RELEASE FOR DISPATCH,¿ ENSURING ADHERENCE TO REQUIRED QUALITY ATTRIBUTES. THE INVESTIGATION INTO COMPLAINT NO. (B)(4) CONCLUDES THAT THE REPORTED MIX-UP WAS MOST LIKELY CAUSED BY INADVERTENT CARRYOVER OF A UNIT FROM A PREVIOUS BATCH AT THE COLLECTION STAGE, PRIOR TO THE ONLINE CHECKWEIGHER OPERATION. A COMPREHENSIVE REVIEW OF MANUFACTURING, PACKING, QUALITY CONTROLS, RECONCILIATION RECORDS, AND WAREHOUSE VERIFICATION CONFIRMED THAT THE EVENT WAS ISOLATED. A VOLUNTARY RECALL WAS INITIATED. CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS), INCLUDING ENHANCED LINE CLEARANCE CONTROLS, PHYSICAL SEGREGATION IMPROVEMENTS, SOP REVISIONS, AND INSTALLATION OF A CAMERA VISION SYSTEM, HAVE BEEN IMPLEMENTED TO PREVENT RECURRENCE. LAST ACTION TAKEN WITH MAGNESIUM SULFATE IN RELATION TO PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF PRODUCT LABEL ON WRONG PRODUCT AND NO ADVERSE EVENT WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.