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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045

D-611-2013

May 04, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 61918
Status
Terminated
Classification
Class II
Quantity
2,137,660 units
Official record key
drug-enforcement:D-611-2013

Official wording

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

Code information: Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12

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