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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

D-176-2013

February 12, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 64441
Status
Terminated
Classification
Class II
Quantity
56,854 Units
Official record key
drug-enforcement:D-176-2013

Official wording

Reason: Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.

Code information: Lot 13-121-JT* * the lot number may be followed by 01

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility