One Lot Of 25% Dextrose Injection, USP (Infant) recalled due to the presence of particulate matter

Posted by on April 24, 2017 11:54 pm
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Categories: US news

Festus iyorah – Fourth Estate Contributor

Lake Forest, IL., United States (4E) – Hospira, Inc., a Pfizer company, 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,” the company said in a recall notice.

Hospira adds that administration of the particulate could also result in 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 this issue for this lot.

The recall involves 25% Dextrose Injection, USP,(Infant) 2.5 grams (250 mg/mL), 10 mL Single-dose prefilled syringe, NDC:0409-1775-10, Lot 58382EV is packaged in a carton containing 1 pre- filled syringe per carton, 5 x 10 syringes per case.

The lot was distributed from Feb. 2016 through Oct. 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. For clinical inquiries, consumers can contact Hospira Global Complaint Management 1-800-441-4100 (8am-5pm CT, M-F) or email at ProductComplaintsPP@hospira.com

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