Drug Safety Alerts

Magnesium Sulfate in Water for Injection Class I Recall

2/26/2016

On February 26, 2016 the United States Food and Drug Administration (FDA) issued a notice regarding a Class I Recall of Magnesium Sulfate in Water for Injection 40 mg/mL Container bag. This recall was issued because the primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. 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.

This recall affects lot number 53-113-JT exp. 11/01/16. The lot went into distribution 2015.

This recall was originally issued to the user/hospital-level on January 6, 2016. The FDA classified this recall as a Class I on February 26, 2016.

CVS/caremark Response:

Please note: This product is not carried by the CVS/caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Hospira Medical Communications at 1‑800‑615‑0187 or contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463-6332) or visit their web site at accessdata.fda.gov/scripts/.