Hospira Voluntarily Recalls One Lot of Heparin for Particulate Matter
Hospira, Inc is initiating a voluntary nationwide user-level recall of one lot of heparin sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% sodium chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with an expiration date of Nov. 1, 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as 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 for this lot. The root cause has not been determined and is under investigation. The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.
Heparin sodium injection in 0.9% sodium chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. In the unlikely event that the 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 that may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
Source: Hospira and FDA