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Class II · ModerateRecall completed

POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORID

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

Does this affect you?
Check your lot numberRx #'s: 0397883 0353267 0408663 0400621 0400621
Where it was soldNationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
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: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

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 / forFranck's Lab Inc., d.b.a. Franck's Compounding Lab
Show the full FDA record
Full product labelPOTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIFFERENT PRODUCTS)
Recalling firmFranck's Lab Inc., d.b.a. Franck's Compounding Lab
DistributionNationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Quantity6 units
Recall initiated2012-05-21
Report date2012-08-22
Recall completed2014-08-15
Recall numberD-1603-2012
ClassificationClass II
FDA statusTerminated
Origin on fileOcala FL United States

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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.