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Hospira 25% Dextrose Injection, USP (Infant) pre-filled syringe – Recall Due to Particulate Matter

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Hospira Inc., is voluntarily recalling one lot (NDC 0408-1775-10, Lot # 58382EV) of 25% Dextrose Injection, USP (Infant) prefilled syringes. Hospira found human hair within an internal sample syringe. If administered to a patient, the human hair particulate could result in local swelling, irritation or blockage of blood vessels, tissue irritation, or systemic allergic response. More severe adverse events due to particulate administration includes localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, and pulmonary infarction. No adverse events have yet been reported with this product.
The recalled lot was distributed to hospitals throughout the United States and Puerto Rico from February 2016 through October 2016. The product comes as a 10mL single-dose prefilled syringe.  Do not use affected product and quarantine immediately.  For additional assistance, call Stericycle at 1-888-570-1678 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Please report any side effects or adverse events regarding the use of this product to the FDA MedWatch Reporting Program.
Additional Information is available at the following links:

  • FDA MedWatch Alert – April 24, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554544.htm
  • Press Release – April 21, 2017
    www.fda.gov/Safety/Recalls/ucm554446.htm