FDAFDA · Food and drugs·Recall number D-0568-2024
Duloxetine 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.
Published July 3, 2024 · Recall initiated: May 13, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Distributor
- Nationwide in the U.S.
- Lot
- Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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