Hospira Recalls One Lot Of 25% Dextrose Injection, USP (Infant)

(RTTNews) - Hospira, Inc., a Pfizer company, voluntarily recalled one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulatematter, identified as human hair, found within an internal sample syringe.

If 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.

Hospira said it has not received reports of any adverse events associated with this issue for this lot to date. This recalled product is indicated for use via slow IV injection to treat symptomatic episodes of hypoglycemia (fasting blood glucose < 40 mg/100 ml) in neonates or older infants to restore depressed blood glucose values and control symptoms.

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 1 pre- filled 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. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately.

This recall is being executed with the knowledge of the U.S. FDA.