Class II
Ongoing
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
This recall is currently active, issued January 15, 2025. It was issued by Rising Pharma Holding, Inc..
- Company
- Rising Pharma Holding, Inc.
- Recall Initiated
- December 30, 2024
- Posted
- January 15, 2025
- Recall Number
- D-0189-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 73,680 bottles
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Distribution
Nationwide
Lot / Code Info
Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
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