FDAFDA · Food and drugs·Recall number D-0189-2025
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Published January 15, 2025 · Recall initiated: December 30, 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 recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Rising Pharma Holding, Inc.
- Distributor
- Nationwide
- Lot
- Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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