Product: Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Reason for recall: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Recall initiated: 20260318
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated