MAGNESIUM SULFATE

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

GREEN AND BLACK PARTICULATE MATTER WAS OBSERVED/A BAG WITH A CONTAMINATED PORT [PRODUCT CONTAMINATION] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF PRODUCT COMPLAINTS OF PRODUCT CONTAMINATION AND NO ADVERSE EVENT FROM THE UNITED STATES. ON 13-MAR-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PHARMACIST VIA AN EMAIL CONCERNING ABOVE MENTIONED PRODUCT COMPLAINTS EXPERIENCED WHILE ON AMNEAL'S MAGNESIUM SULFATE. PRODUCT DETAILS INCLUDED MAGNESIUM SULFATE IN WATER FOR INJECTION, 2 G/50 ML (NDC: 70121-1719-1, LOT NO: AH250168, EXP DATE: 30-SEP-2027) FOR AN UNKNOWN INDICATION. IT WAS REPORTED THAT, IMMEDIATELY AFTER REMOVING A BAG FROM THE OVERWRAP TO PREPARE IT FOR ADMINISTRATION, THE REPORTER IDENTIFIED A BAG WITH A CONTAMINATED PORT. GREEN AND BLACK PARTICULATE MATTER WAS OBSERVED. LAST ACTION TAKEN WITH MAGNESIUM SULFATE IN RELATION TO PRODUCT CONTAMINATION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT CONTAMINATION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF PRODUCT CONTAMINATION AND NO ADVERSE EVENT WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW-UP (#1) INFORMATION WAS RECEIVED ON 18-MAR-2026. SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHARMACIST VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED REPORTER CONTACT INFORMATION, AND NARRATIVE WAS UPDATED. IT WAS REPORTED THAT, THE POUCH WAS PROVIDED TO NURSE, AND UPON STAGING IT FOR USE, SHE OPENED THE POUCH AND REMOVED THE IV BAG. AT THAT TIME, SHE NOTICED THAT THE PORT AREA HAD ¿GREEN AND BLACK LIKE PARTICLES¿ ON IT. SOMEONE MENTIONED THAT IT LOOKED LIKE MOLD, BUT SHE STATED THAT SHE DID NOT THINK IT WAS MOLD, ALTHOUGH SHE WAS NOT SURE. SHE QUARANTINED THE PRODUCT IN HER OFFICE. UPON NOTICING THE DISCOLORATION, THE NURSE INFORMED THE PHARMACIST ON THE FLOOR AND DID NOT USE THE PRODUCT. ANOTHER POUCH WAS USED INSTEAD, AND IT WAS FINE AND DID NOT CONTAIN ANY DISCOLORATION. SHE NOTED THAT THE OVERWRAP IS NOT PRE-REMOVED AND IS PROVIDED WHEN NEEDED. LAST ACTION TAKEN WITH MAGNESIUM SULFATE IN RELATION TO PRODUCT CONTAMINATION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT CONTAMINATION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF PRODUCT CONTAMINATION AND NO ADVERSE EVENT WITH MAGNESIUM SULFATE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.