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Recall Observatory FDA recall evidence

Drug product

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.

D-262-2013

January 25, 2013

Class I

Product summary

Firm
Hospira Inc.
Event
Event 64197
Status
Terminated
Classification
Class I
Quantity
143,136 flexible containers
Official record key
drug-enforcement:D-262-2013

Official wording

Reason: Non-Sterility: Confirmed customer complaint of product contaminated with mold.

Code information: Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contaminated with mold