FDAFDA · Food and drugs·Recall number D-0483-2024
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Published May 15, 2024 · Recall initiated: April 29, 2024
Status when published: Ongoing — 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
- US Nationwide.
- Lot
- 220456: Exp. Feb 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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