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Class II · ModerateRecall completed

Potassium Chloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: P319160, Exp 06/30/15
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBaxter Healthcare Corporation
Brand namePOTASSIUM CHLORIDE
Generic namePOTASSIUM CHLORIDE
Active ingredient(s)POTASSIUM CHLORIDE
Distributed by / forBaxter Healthcare Corp.
NDC0338-0709-48
Show the full FDA record
Full product labelPotassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Recalling firmBaxter Healthcare Corp.
DistributionNationwide
Quantity63,360 container bags
Recall initiated2014-11-10
Report date2014-12-03
Recall completed2016-11-03
Recall numberD-0256-2015
ClassificationClass II
FDA statusTerminated
Origin on fileDeerfield IL United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.