Hospira Issues Voluntary Nationwide Recall for one Lot of 25% Dextrose Injection

Hospira is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe.

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.

The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Lot information includes 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. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

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. To report adverse events or product complaints, contact Hospira Global Complaint Management at 1-800-441-4100 or email ProductComplaintsPP@hospira.com. For medical inquiries, contact Pfizer Medical Information at 1-800-615-0187.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting.