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Recall Observatory FDA recall evidence

Drug product

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045

D-616-2013

May 04, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 61918
Status
Terminated
Classification
Class II
Quantity
216,396 units
Official record key
drug-enforcement:D-616-2013

Official wording

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

Code information: Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-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