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Recall Observatory FDA recall evidence

Drug product

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

D-614-2013

May 04, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 61918
Status
Terminated
Classification
Class II
Quantity
267,288 units
Official record key
drug-enforcement:D-614-2013

Official wording

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

Code information: Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12

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