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Class II · ModerateRecall completed

Duloxetine Delayed-release Capsules USP

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

Does this affect you?
Check your lot numberLot: 18103 Exp. 11/18
Where it was soldNationwide in the USA
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: slightly elevated levels of phthalic acid.

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 / forAvKARE, Inc., Pulaski, TN 38478
NDC50268-283-15
Show the full FDA record
Full product labelDuloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Recalling firmAVKARE Inc.
DistributionNationwide in the USA
Quantity274 cartons
Recall initiated2017-10-06
Report date2017-11-08
Recall completed2019-03-11
Recall numberD-0055-2018
ClassificationClass II
FDA statusTerminated
Origin on filePulaski TN 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.