Drug 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.

D-0478-2026

March 18, 2026

Class I

Product summary

Firm: Amneal Pharmaceuticals, LLC
Event: Event 98587
Status: Ongoing
Classification: Class I
Quantity: 784 (12x100mL) cartons
Official record key: drug-enforcement:D-0478-2026

Official wording

Reason: 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.

Code information: Lot: AH250162, Exp 8/31/2027

Distribution pattern: U.S.A. Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.