FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Tacrolimus

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

Does this affect you?
Check your lot numberLots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
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

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

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 nameTACROLIMUS
Generic nameTACROLIMUS
Active ingredient(s)TACROLIMUS
Distributed by / forSandoz Incorporated
NDC0781-2102-01
Show the full FDA record
Full product labelTacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Recalling firmSandoz Incorporated
DistributionNationwide
Quantity12,521 bottles
Recall initiated2013-10-22
Report date2014-01-01
Recall completed2014-07-10
Recall numberD-383-2014
ClassificationClass II
FDA statusTerminated
Origin on fileBroomfield CO 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.