September 16th, 2014

Heparin Recall Due to Human Hair

Heparin Recall Due to Human Hair

September 15, 2014

The U.S. Food and Drug Administration (FDA) announced that Hospira is issuing a voluntary recall of heparin sodium due to particulate matter.

The recall is of one lot of 1,000 USP heparin units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03.  The affected lot is 41-046-JT with an expiration date of November 1, 2015.  The lot was distributed between June and August 2014.

Hospira confirmed that the particulate matter was human hair, according to the FDA.  The statement described its location as “sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.”

Discontinuation and quarantine of the affected units should occur immediately.  Hospira has arranged for the collection of the products via Stericycle.  If in possession of the affected products you can call 1-855-201-4337.

Hospira has not received any reports of adverse events.

Reference:

1. Hospira issues a voluntary nationwide 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, due to particulate matter [press release]. www.fda.gov. 2014 Sep 11.

PLN Topics:
Anticoagulation
Cardiology
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