Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
This recall is currently active, issued March 26, 2025. It was issued by Rising Pharma Holding, Inc..
- Company
- Rising Pharma Holding, Inc.
- Recall Initiated
- March 5, 2025
- Posted
- March 26, 2025
- Recall Number
- D-0277-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1223 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 in the USA.
Lot / Code Info
Lot #: DTB23111A, Exp 8/31/2025
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