Magnesium Sulfate in Water for Injection, by Hospira, Recalled due to Incorrect Barcode Labeling on the Primary Container
As the FDA announced, Hospira, Inc. is recalling 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) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling.
Background of Magnesium Sulfate in Water for Injection, by Hospira
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).
FDA Alert on Magnesium Sulfate in Water for Injection, by Hospira
According to the announcement “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.
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.”
FDA Recommendation on Magnesium Sulfate in Water for Injection, by Hospira
“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 which 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 is notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-877-650-7695 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.”
Contacting the FDA to report cases with Magnesium Sulfate in Water for Injection, by Hospira
In case of detection of adverse events or side effects related to the use of Magnesium Sulfate in Water for Injection, by Hospira, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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