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Recall Observatory FDA recall evidence

Drug product

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

D-0862-2017

April 21, 2017

Class I

Product summary

Firm
Hospira Inc.
Event
Event 77111
Status
Ongoing
Classification
Class I
Quantity
71,550 syringes
Official record key
drug-enforcement:D-0862-2017

Official wording

Reason: Presence of Particulate Matter: human hair found within an internal sample syringe.

Code information: Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter