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Class III · Lower riskRecall completed

Duloxetine

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

Does this affect you?
Check your lot numberLot #: 142391, Exp 10/2016
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

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

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 byLaboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487 foreign manufacturer
Brand nameDULOXETINE
Generic nameDULOXETINE HYDROCHLORIDE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forBreckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
NDC51991-748-10
Show the full FDA record
Full product labelDuloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Recalling firmBreckenridge Pharmaceutical, Inc
DistributionNationwide
Quantity595 Bottles
Recall initiated2015-10-21
Report date2015-11-18
Recall completed2015-12-24
Recall numberD-0181-2016
ClassificationClass III
FDA statusTerminated
Origin on fileBerlin CT United States

Related

Duloxetine recallsRecent drug recallsCheck another medication

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.