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Recall Observatory FDA recall evidence

Drug product

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

D-1606-2014

September 08, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp
Event
Event 69130
Status
Terminated
Classification
Class II
Quantity
148632 bags
Official record key
drug-enforcement:D-1606-2014

Official wording

Reason: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Code information: Lot P318220, EXP 05/31/15

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.