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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09

D-1096-2014

February 11, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 67605
Status
Terminated
Classification
Class II
Quantity
603,768 bags
Official record key
drug-enforcement:D-1096-2014

Official wording

Reason: Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.

Code information: Lot 34-609-FW; Exp 10/15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility