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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

D-608-2013

June 06, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 65400
Status
Terminated
Classification
Class II
Quantity
676,872 containers
Official record key
drug-enforcement:D-608-2013

Official wording

Reason: Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

Code information: Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility