Amneal Pharmaceuticals LLC said it is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. The action, taken with the knowledge of the U.S. Food and Drug Administration, covers lot AH250162. The product was shipped nationwide to wholesalers and distributors over a recent distribution period.
Why the Product Is Being Recalled
The company reported that a pouch labeled as Magnesium Sulfate in Water for Injection was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. Amneal said a delay in magnesium treatment could pose serious risks for pregnant patients with preeclampsia or eclampsia, including seizures and potentially long-lasting harm. In preterm pregnant patients, delayed magnesium therapy could also lead to long-term morbidity for the newborn because of prematurity-related complications.
If Tranexamic Acid, or TXA, is given by mistake, possible adverse effects include blood clotting, seizures, hypersensitivity reactions, visual changes, and dizziness. Amneal said it has not received any reports of adverse events tied to this recall.
Recalled Product Details
The recall covers Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag.
NDC 70121-1720-3.
Lot AH250162.
Packaged as 12 x 100mL pouches per carton.
How to Identify the Recalled Lots
Health care providers should look for Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag with NDC 70121-1720-3 and lot AH250162.
Amneal said the product is packaged as 12 x 100mL pouches to a carton, and that each Tranexamic Acid IV bag is clearly labeled with the product name and a readable barcode.
The recall notice also includes product images.
For detailed information about this recall, please visit:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp
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