FDAHealthDecember 30, 2024
Rising Pharma Holding, Inc. — 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
⚠️ CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 30, 2024
Nationwide
What's affected?
- Product
- 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
- Lot code
- DT2023003A
Additional details
Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 73,680 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.