An incorrect bar code on a drug's primary container has lead to a recall.
Hospira Inc. is voluntarily recalling 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 bar code on the primary bag labeling, FDA reports on its Web site.
"The bar code on the overwrap is correct; however, there is potential for the primary container bar code to be mislabeled with the bar code 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," it was reported.
Administering 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, it is reported.
Hospira reports that it has not heard of any adverse events associated with this issue for this lot.
Magnesium sulfate in 5% dextrose injection, USP is packaged in 50/100 mL container bags and sold 24 bags per carton (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015); this lot was distributed nationwide in the U.S. to wholesalers, distributors, and hospitals from October 2014 to January 2015.
Hospira is investigating.