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Amneal Pharmaceuticals, LLC: 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, Manufactu

DrugsSource: FDA (drug) · Date: 2026-04-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Amneal Pharmaceuticals, LLC
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 / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2026-03-18
Code info
Lot: AH250162, Exp 8/31/2027
Product quantity
784 (12x100mL) cartons
Voluntary mandated
Voluntary: Firm initiated
City
Bridgewater
State
NJ
Country
United States
Event id
98587
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