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Recall Observatory FDA recall evidence

Drug product

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

D-0827-2016

March 08, 2016

Class II

Product summary

Firm
Hospira Inc.
Event
Event 73472
Status
Terminated
Classification
Class II
Quantity
11256 bags
Official record key
drug-enforcement:D-0827-2016

Official wording

Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Code information: Lot# 48-010-JT, Exp 12/16

Distribution pattern: US: Nationwide and Singapore

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination