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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,

D-183-2013

January 08, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 64001
Status
Terminated
Classification
Class II
Quantity
325,056 bags
Official record key
drug-enforcement:D-183-2013

Official wording

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

Code information: Lot Number 02-117-JT Exp. 02/13

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility