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Recall Observatory FDA recall evidence

Drug product

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

D-0256-2015

November 10, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 69518
Status
Terminated
Classification
Class II
Quantity
63,360 container bags
Official record key
drug-enforcement:D-0256-2015

Official wording

Reason: Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Code information: Lot #: P319160, Exp 06/30/15

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error