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Recall Observatory FDA recall evidence

Drug product

Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01

D-106-2013

October 25, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 63589
Status
Terminated
Classification
Class II
Quantity
361,600/1-mL ampules
Official record key
drug-enforcement:D-106-2013

Official wording

Reason: Presence of Particulates; may contain glass particles

Code information: Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulates