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Recall Observatory FDA recall evidence

Drug product

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

D-0668-2016

January 05, 2016

Class I

Product summary

Firm
Hospira Inc.
Event
Event 72996
Status
Terminated
Classification
Class I
Quantity
213,600 bags
Official record key
drug-enforcement:D-0668-2016

Official wording

Reason: Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

Code information: Lot: 53-113-JT, Exp 1NOV2016

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled