FDAFDA · Food and drugs·Recall number D-0105-2025
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Published December 11, 2024 · Recall initiated: November 19, 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
- a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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