Hospira announced a voluntary recall of 1 lot of 25% Dextrose Injection, USP, (Infant) prefilled syringe due to the presence of human hair found in an internal sample syringe.
The 25% Dextrose Injection, USP, (Infant) is indicated for use as a slow intravenous (IV) injection to treat symptomatic episodes of hypoglycemia (fasting blood glucose <40mg/100mL) in neonates or older infants to restore depressed blood glucose values and control symptoms.
If a drug with particulate matter is given to a patient, it may lead to local swelling, irritation of blood vessel or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. It can further result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction. The recall alert emphasizes the direction indicated on the labeling to visually inspect for particulate matter and discoloration prior to administration in efforts to reduce the risk of possible adverse events.
The affected product has Lot #58382EV with expiration date 1OCT2017. It is supplied as a 10mL single-dose prefilled syringe in 5×10 cases. The lot was distributed from February 2016 through October 2016 across the United States and Puerto Rico.
The Company has not received any reports of any adverse events related to the affected lot. Those with an existing inventory of the recalled lot should discontinue use and distribution and immediately quarantine the product.
For more information call (888) 570-1678 or visit FDA.gov.