Injections Recalled Due to Labeling Error, Contamination

Hospira is voluntarily recalling a mislabeled lot of its injectable anti-seizure medication, magnesium sulfate in 5% dextrose, as well as 1 lot of its 0.9% sodium chloride injection, following a confirmed report of particulate in a single unit.

The recalled sodium chloride (lot number 45-110-C6) is packaged in 250 mL VisIV flex containers, which were distributed from December 2014 through January 2015. The mislabeled magnesium sulfate (lot number 42-120-JT), which was found to have an incorrect barcode on the primary bag labeling, was distributed from October 2014 to January 2015.

The particulate found in the contaminated sodium chloride unit was confirmed by Hospira to be a human hair. While it is unlikely to happen, foreign material may pass through the intravenous catheter during the product’s administration, potentially leading to localized inflammation, phlebitis, allergic reaction, granuloma formation, microembolic effects, or capillary obstruction.

The FDA noted that the incorrect magnesium sulfate barcodes were also unlikely to cause patient harm, as the barcode on the product’s overwrap and the text on its primary container and overwrap are correct. However, the agency warned that the mistake could cause delays in treatment, possibly leading to life-threatening seizures, stroke, cerebral hemorrhage, and maternal death, as well as risks to any fetuses carried by pregnant patients.

There have been no reports of adverse events associated with either issue, according to an FDA press release.

Hospira has notified its customers to examine their inventory immediately and quarantine, discontinue distribution, and return any stock of the recalled lots. In addition, the manufacturer has instructed its customers to identify and notify anyone who may have received further distributed products.

Those with questions regarding this recall should contact Stericycle at 1-866-382-9260 between 8 a.m. and 5 p.m. Eastern Standard Time, Monday through Friday.

In addition to contacting their health care professionals, patients who have experienced adverse reactions to the affected product should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.