Hospira issues a voluntary nationwide recall of one lot of magnesium sulfate in water for injection

Recall issued as a result of a customer reporting an incorrect barcode on the primary bag labeling.

The product has a barcode identifying the product contents on both the overwrap and on the primary container. 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 INJECTION. The product is labeled with the correct printed name on the primary container and overwrap. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

If the incorrect barcode on Magnesium Sulfate in Water for Injection is not detected prior to dispensing or administration to a patient, and the product is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the primary container and overwrap are correct. However, if detected, there is the potential for delay in treatment of Magnesium Sulfate in Water for Injection that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise. 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.

Although serious in nature, the likelihood of this risk to occur is low due to the high detectability of this nonconformance. Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively.

The product is packaged 50 mL fill, in 100 mL container bags and sold 24 bags per carton (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016). The lot was distributed nationwide in the US to wholesalers, distributors and hospitals from September 2015 to November 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.