Medicine recalls
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| The United States: Amneal Pharmaceuticals LLC issues voluntary nationwide recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) due to a product mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL |
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The US Food and Drug Administration (FDA) announces that Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag (lot number: AH250162) to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL.
There is a reasonable probability that delay in receiving magnesium therapy could result in life-threatening or long-term morbidity in pregnant individuals with preeclampsia or eclampsia due to the potential to develop seizures. Additionally, delay in receiving magnesium therapy in preterm pregnant individuals could result in long-term morbidity for the preterm neonate due to complications of prematurity. Amneal has not received any adverse event reports related to this recall. If Tranexamic Acid is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.
Magnesium Sulfate in Water for Injection (NDC 70121-1720-3) is indicated for the prevention and control of seizures in preeclampsia and eclampsia. Lot AH250162, is packaged 12 x 100mL pouches to a carton. Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Mar 25, 2026
Issued at HKT 17:15
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