Hospira, Inc has issued a voluntary recall of one lot of magnesium sulfate in water for injection (0.325 mEq Mg**/mL) after a customer report of an incorrect barcode on the primary bag labeling, the company has announced.
The product is packaged 50 mL fill, in 100-mL container bags, and sold 24 bags per carton. It has the NDC 0409-6729-24, lot number 53-113-JT, and expiration date November 1, 2016.
According to a company press release posted January 5, 2016, on the US Food and Drug Administration website, the product has a barcode on both the overwrap and 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."
"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 and may require medical intervention," the company said.
Magnesium sulfate in water for injection is used for the prevention of seizures in preeclampsia and the control of seizures in eclampsia.
The recalled lot was distributed nationwide in the United States to wholesalers, distributors, and hospitals from September 2015 to November 2015. Hospira has initiated an investigation to determine the root cause of the error and take appropriate corrective and preventive actions.
Customers with an existing inventory of the recalled lot are advised to stop use and distribution and quarantine the product immediately and to notify all users in their facility and any additional facilities where the product may have been distributed.
Hospira is notifying its direct customers via a recall letter and is arranging for the recalled product to be returned to Stericycle. For additional assistance, customers may call Stericycle at 1-877-650-7695 between the hours of 8 a.m. and 5 p.m. ET, Monday through Friday.
Hospira Recalls One Lot of Magnesium Sulfate for Injection. Medscape. Jan 06, 2016.