Hospira Inc. has initiated a US-wide recall of 1 lot of heparin sodium, following a customer report of particulate in a single unit.
The recall affects lot 41-046-JT of 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL (NDC 0409-7620-03; expiration date November 1, 2015).
The foreign particle found in a unit from this lot was a human hair sealed between the tube and the film at the round seal of the unused administrative port on the non-print side of the container.
To date, Hospira has not received reports of any adverse events associated with this issue. The root cause has not been determined and is under investigation.
Heparin sodium injection is indicated as an anticoagulant to maintain catheter patency. In the event that a particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
Capillaries may become occluded. Patients with a pre-existing condition of trauma or another medical condition that adversely affects the microvascular blood supply are at an increased risk.
The lot of heparin affected by this recall was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.
Anyone with existing inventory should stop use and distribution and quarantine the product immediately. Customers should also inform potential users of this product about the recall.
Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for the impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8 am and 5pm ET, Monday through Friday.
For clinical inquiries, contact Hospira. To report adverse events or product complaints, call 1-800-441-4100 (8 am to 5 pm CT, Monday through Friday) or email ProductComplaintsPP@hospira.com.
For medical inquiries, call 1-800-615-0187 (available 24 hours a day, 7 days per week) or email medcom@hospira.com.
Adverse reactions or quality problems associated with this product can be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting Program.
