Hospira, a Pfizer company, has issued a nationwide recall of 1 lot of 25% Dextrose Injection, USP (Infant), pre-filled syringe to the hospital/user level, according to FDA officials. The injection has been recalled due to the presence of particulate matter, identified as human hair, found within an internal sample syringe.
Dextrose Injection, USP (Infant), is indicated for use via slow IV injection to treat symptomatic episodes of hypoglycemia in infants to restore depressed blood glucose values and control symptoms. The recalled lot is NDC:0409-1775, Lot 58382EV, expiry date 1OCT2017. The lot was distributed from February 2016 through October 2016.
If administered to a patient, the particulate could cause local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response. Other possible effects include localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction.
Hospira has not received reports of any adverse events associated with the recalled lot. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately.
Hospira issues a voluntary nationwide recall for one lot of 25% Dextrose Injection, USP (Infant) due to the presence of particulate matter [news release]. FDA’s website. . Accessed April 24, 2017.