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Class II · ModerateRecall completed

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag

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

Does this affect you?
Check your lot numberAll Sterile Compounded Products within Expiry
Where it was soldNationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
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

Lack of Assurance of Sterility

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

Distributed by / forPharmakon Pharmaceuticals, Inc.
NDC45183-0173-02
Show the full FDA record
Full product labelPotassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
Recalling firmPharmakon Pharmaceuticals, Inc.
DistributionNationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Quantity40
Recall initiated2016-04-20
Report date2016-07-20
Recall completed2018-01-11
Recall numberD-1271-2016
ClassificationClass II
FDA statusTerminated
Origin on fileNoblesville IN 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.