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Class II · ModerateRecall completed

Duloxetine

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

Does this affect you?
Check your lot numberLot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Where it was soldNationwide in the U.S.
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

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

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 byGolden State Medical Supply, Inc.
Brand nameDULOXETINE
Generic nameDULOXETINE HYDROCHLORIDE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forGolden State Medical Supply Inc.
NDC60429-165-30
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Recalling firmGolden State Medical Supply Inc.
DistributionNationwide in the U.S.
Quantity21,655 (30 count bottle), 34,149 (90 count bottle)
Recall initiated2024-05-13
Report date2024-07-03
Recall completed2025-03-20
Recall numberD-0568-2024
ClassificationClass II
FDA statusTerminated
Origin on fileCamarillo CA 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.