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Recall Observatory FDA recall evidence

Drug product

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01

D-0145-2017

October 19, 2016

Class III

Product summary

Firm
Sandoz Inc
Event
Event 75563
Status
Terminated
Classification
Class III
Quantity
139,430 vials
Official record key
drug-enforcement:D-0145-2017

Official wording

Reason: Labeling: Missing Label

Code information: Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19

Distribution pattern: WI

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing