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Class II · ModerateRecall completed

Potassium Chloride Oral Solution

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

Does this affect you?
Check your lot numberLot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Where it was soldDomestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.
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

Defective Container: Leakage of unit dose cups that may occur at the seal.

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 byVistaPharm, Largo, FL 33771
Distributed by / forVistaPharm, Inc.
NDC66689-047-01
Show the full FDA record
Full product labelPotassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.
Recalling firmVistaPharm, Inc.
DistributionDomestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.
Quantity13,609 cases
Recall initiated2017-01-18
Report date2017-02-15
Recall completed—
Recall numberD-0469-2017
ClassificationClass II
FDA statusTerminated
Origin on fileLargo FL United States

Related

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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.