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Mislabeled Magnesium Sulfate Has Heparin Barcode; Serious Birthing Injury Risk


Hospira, Inc., of Lake Forest, IL, has recalled one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct. However, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.

 

If the incorrect barcode on Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/ mL is not detected prior to dispensing or administration to a patient, and the product is administered based on the printed name, administration of the magnesium sulfate drug product to a patient who is prescribed heparin and in whom the magnesium sulfate is contraindicated can result in serious adverse events related to the drug’s pharmacologic action and may require medical intervention. If the mislabeling is detected, there is the potential for delay in treatment of magnesium sulfate in 5% dextrose that can result in life-threatening seizures, stroke, cerebral hemorrhage, and maternal death with attendant risks to the fetus, including fetal demise.

 

Magnesium sulfate in 5% dextrose injection, USP, is a prescription product administered intravenously for the prevention and control of seizures in preeclampsia and eclampsia, respectively. The product is packaged in 50/100 mL container bags and sold 24 bags per carton. The lot was distributed nationwide in the U.S. to wholesalers, distributers and hospitals from October 2014 to January 2015.

 

See the Recall

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability

 

 

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