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Recall Observatory FDA recall evidence

Drug product

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48

D-615-2013

May 04, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 61918
Status
Terminated
Classification
Class II
Quantity
74,256 units
Official record key
drug-enforcement:D-615-2013

Official wording

Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Code information: Lot #: 11-161-JT, Exp 11/13

Distribution pattern: Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility