Skip to content
Recall Observatory FDA recall evidence

Drug product

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.

D-1036-2014

January 09, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 67317
Status
Terminated
Classification
Class II
Quantity
27780 bags
Official record key
drug-enforcement:D-1036-2014

Official wording

Reason: Lack of Assurance of Sterility; potential leakage from administrative port.

Code information: Lot #: 26-125-JT, Exp: 8/14

Distribution pattern: Nationwide including Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility