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Class II · ModerateRecall completed

Duloxetine Delayed-Release Capsules

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

Does this affect you?
Check your lot numberLot #: 48D001, Exp. 5/2015; 48D002, Exp. 9/2015
Where it was soldNationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
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 Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

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 / forTeva Pharmaceuticals USA, Sellersville, PA 18960
NDC0093-7542-06
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
Recalling firmTeva Pharmaceuticals USA
DistributionNationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
Quantity127,585 Bottles
Recall initiated2014-03-04
Report date2014-04-09
Recall completed2014-11-12
Recall numberD-1182-2014
ClassificationClass II
FDA statusTerminated
Origin on fileHorsham PA 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.