Hospira has announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose 10mg/mL Injection after confirmed customer reports of an incorrect barcode on the primary bag labeling.
Though the barcode on the overwrap is correct, there is a possibility for the primary container barcode to be mislabeled as the Heparin Sodium 2000 USP units/1000mL in 0.9% Sodium Chloride Injection barcode. The product does contain the correct printed name on the primary container and overwrap.
Patient harm is unlikely even if the incorrect barcode goes undetected prior to dispensing or administration since the barcode on the overwrap and text on the primary container and overwrap are correct. However, if it is detected, a delay in administration of Magnesium Sulfate in 5% Dextrose could lead to life-threatening seizures, stroke, cerebral hemorrhage, and maternal death; fetal demise may also be possible.
Magnesium Sulfate in 5% Dextrose Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. The affected product is supplied in 50/100mL container bags and sold in 24-count cartons. It contains Lot# 42-120-JT with an expiration date of 1DEC2015.
Anyone with the affected product lot should quarantine the product immediately. Hospira will be notifying its customers via a recall letter and is arranging for product return.
For more information call (888) 382-9260 or visit FDA.gov.