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Class II · ModerateRecall completed

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection

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

Does this affect you?
Check your lot numberLot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15
Where it was soldNationwide, Puerto Rico, and U.S. Virgin Islands.
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: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

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 byHospira, Inc., Lake Forest, IL 60045
Distributed by / forHospira Inc.
NDC0409-7902-09
Show the full FDA record
Full product labelPotassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
Recalling firmHospira Inc.
DistributionNationwide, Puerto Rico, and U.S. Virgin Islands.
Quantity836,460 bags
Recall initiated2014-10-14
Report date2014-12-03
Recall completed2015-12-28
Recall numberD-0278-2015
ClassificationClass II
FDA statusTerminated
Origin on fileLake Forest 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.