Amneal Recalls Magnesium Sulfate After Drug Mix-Up Found in Pregnancy Medication
Amneal Pharmaceuticals recalls magnesium sulfate after a pouch intended for pregnant women was found containing tranexamic acid instead. The medication mix-up could cause serious adverse events including seizures and blood clotting if administered incorrectly.
Amneal Pharmaceuticals is recalling magnesium sulfate after a pouch of the pregnancy medication was found containing the wrong drug. A pouch of magnesium sulfate, used to prevent seizures from preeclampsia and eclampsia, was found containing an IV bag of the drug tranexamic acid, a medication known to cause seizures. If tranexamic acid is inadvertently administered, it could result in adverse events including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.
Officials said the risk of a mix-up is low because hospitals have safety checks in place and the medications were both clearly labeled. The labeled tranexamic acid IV bag was placed in the wrong sleeve, which was labeled magnesium. Amneal says they conducted a thorough examination of 74% of the magnesium sulfate pouches that remain in their possession and no other product mix issue was identified in this inspection.
Hospitals that have the recalled magnesium sulfate in water for injection should stop using and return the product to Amneal. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Hospitals with questions regarding this recall can contact Amneal Pharmaceuticals by phone at 833-582-0812.