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Recall Observatory FDA recall evidence

Drug product

HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54

D-184-2013

October 22, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 63522
Status
Terminated
Classification
Class II
Quantity
11,412 bags
Official record key
drug-enforcement:D-184-2013

Official wording

Reason: Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.

Code information: Lot # 10-199-JT Exp. 10/13

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility