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Class III · Lower riskRecall completed

Bumetanide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: a) CU6131, b) CW1161
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

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

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 bySandoz Inc
Brand nameBUMETANIDE
Generic nameBUMETANIDE
Active ingredient(s)BUMETANIDE
Distributed by / forSandoz Inc
Show the full FDA record
Full product labelBumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
Recalling firmSandoz Inc
DistributionNationwide
Quantity11,496 bottles (100 count) and 62 bottles (500 count)
Recall initiated2013-11-06
Report date2013-12-18
Recall completed2014-05-29
Recall numberD-341-2014
ClassificationClass III
FDA statusTerminated
Origin on fileWilson NC 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.