PlainRecalls
FDA Drug Critical Class I Terminated

HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03

Reported: December 31, 2014 Initiated: September 11, 2014 #D-0324-2015

Product Description

HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03

Reason for Recall

Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

Details

Recalling Firm
Hospira Inc.
Units Affected
63,378 flexible container units
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03. Recalled by Hospira Inc.. Units affected: 63,378 flexible container units.
Why was this product recalled?
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 31, 2014. Severity: Critical. Recall number: D-0324-2015.