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Class III · Lower riskRecall completed

candesartan cilexetil

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

Does this affect you?
Check your lot numberLot #: 3007330, Exp 11/2014
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 Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

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 / forSandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India
NDC0781-5938-92
Show the full FDA record
Full product labelcandesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Recalling firmSandoz, Inc
DistributionNationwide
Quantity6,336 bottles
Recall initiated2014-10-02
Report date2014-12-10
Recall completed2015-07-23
Recall numberD-0288-2015
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ 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.