FDAFDA · Food and drugs·Recall number D-0009-2025
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Published October 23, 2024 · Recall initiated: October 10, 2024
Status when published: Completed — 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 N-nitroso-duloxetine impurity above FDA recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Distributor
- Product was distributed nationwide within the United States
- Lot
- Lot #: 220128, Exp. Date 12/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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