Hospira Recalls One Lot of Magnesium Sulfate

January 6, 2016

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

According to a Jan. 5, 2015 press release, Hospira has voluntarily recalled one lot of magnesium sulfate in water for injection (0.325 mEq Mg/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) due to an incorrect barcode on the primary bag label, which was reported by a customer. While the barcode on the overwrap is correct and the product name is printed correctly on the primary container and overwrap, the company states, “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 company states that patient harm is unlikely if the product is administered based on the name printed on the label. A delay in product administration, however, could happen if the incorrect barcode on the primary bag label is noticed. A delay in treatment could result in “life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.” According to the company, “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.”

The affected lot 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 to wholesalers, distributors, and hospitals in the United States from September 2015 to November 2015.

Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Source: FDA