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Recall Observatory FDA recall evidence

Drug product

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

D-1076-2015

March 06, 2015

Class I

Product summary

Firm
Hospira Inc.
Event
Event 70643
Status
Terminated
Classification
Class I
Quantity
181,704 bags
Official record key
drug-enforcement:D-1076-2015

Official wording

Reason: Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Code information: Lot: 42-120-JT, Exp 01DEC2015

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled