Hospira Recalls One Lot of 25% Dextrose Injection

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The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.

On April 21, 2017 FDA announced that Hospira is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) prefilled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. The 25% Dextrose Injection, USP, (Infant) 2.5 grams (250 mg/mL), 10 mL single-dose prefilled syringe, NDC:0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017 is packaged in a carton containing one prefilled syringe per carton, 5 x 10 syringes per case. The lot was distributed from February 2016 through October 2016 nationwide in the United States and Puerto Rico, Hospira said in a statement.

In the event that the particulate is administered to a patient, it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels, and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.


Source: FDA