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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

D-623-2013

February 27, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 65061
Status
Terminated
Classification
Class II
Quantity
317,280 bags
Official record key
drug-enforcement:D-623-2013

Official wording

Reason: Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

Code information: Lot: P293118; Exp Date: 10/13

Distribution pattern: Nationwide and Singapore

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling Wrong Barcode; It may display wrong