Hospira, Inc., a Pfizer company, has announced a voluntary recall of one lot of the anti-seizure drug, MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL to the user level due to a confirmed customer report of 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 the blood thinner, 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 death. 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 U.S. 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.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations that may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.
See the Recall
See the FDA Safety Announcement
See also Medical Law Perspectives, August 2014 Report: Epilepsy and Seizure Disorders: Malpractice in Diagnosis and Treatment
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication