TOPIC: Magnesium Sulfate in Water for Injection, USP 4 g/100 mL by Amneal Pharmaceuticals: Recall - Due to a Product Mix-up with Tranexamic Acid in 0.7 % Sodium Chloride Injection, 10 mg/mL
AUDIENCE: Patient, Health Care Professional, Pharmacy, Risk Manager
ISSUE: Amneal Pharmaceuticals is recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100 mL, IV bag, 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.
Risk Statement: 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 (TXA) is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.
The likelihood of such a mix-up reaching a patient is considered low as hospital medication-administration controls provide multiple safety checks prior to administration. Amneal conducted a thorough examination of 74 % of the Magnesium Sulfate pouches that remain in our possession. No product mix issue was identified in this inspection. Additionally, each Tranexamic Acid IV bag is clearly labeled with the product name and includes a readable bar code, making incorrect identification readily detectable.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
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Magnesium Sulfate in Water for Injection (NDC 70121-1720-3) is indicated for the prevention and control of seizures in preeclampsia and eclampsia.
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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.
RECOMMENDATIONS:
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Hospitals that have Magnesium Sulfate in Water for Injection which is being recalled should stop using and return the product to Amneal. Product should be returned to Amneal Pharmaceuticals, Magnesium Sulfate Recall Coordinator, 21 Colonial Drive, Piscataway, NJ 08854.
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Hospitals with questions regarding this recall can contact Amneal Pharmaceuticals by Phone: 833-582-0812 Monday-Friday. Fax: 631-983-2595. E-mail to: MagnesiumSulfateRecall@amneal.com.
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