FDAHealthMarch 5, 2025
Rising Pharma Holding, Inc. — 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
⚠️ 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
- March 5, 2025
Nationwide in the USA.
What's affected?
- Product
- 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
- Lot code
- DTB23111A
Additional details
Lot #: DTB23111A, Exp 8/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1223 bottles.
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