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Recall Observatory FDA recall evidence

Drug product

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

D-0727-2016

February 02, 2016

Class III

Product summary

Firm
Hospira Inc.
Event
Event 73313
Status
Ongoing
Classification
Class III
Quantity
10,778 bags
Official record key
drug-enforcement:D-0727-2016

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

Code information: Lot #: 56-853-FW, Exp 01AUG2017

Distribution pattern: Nationwide and Hong Kong

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing