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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

D-619-2013

May 04, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 61918
Status
Terminated
Classification
Class II
Quantity
2,933,936 units
Official record key
drug-enforcement:D-619-2013

Official wording

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

Code information: Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12

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