FDAHealthDecember 30, 2024
Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings
⚠️ 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 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Lot code
- DT3023051A
Additional details
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 42,527 bottles.
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