Status
Ongoing
Drug Enforcement D-0277-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Classification
Class II
Report Date
March 26, 2025
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 1223 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Rising Pharma Holding, Inc.
- Address
-
2 Tower Center Blvd Ste 1401, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0277-2025
- Event ID
- 96427
- Recall initiation date
- March 5, 2025
- Center classification date
- March 14, 2025
- Code info
- Lot #: DTB23111A, Exp 8/31/2025
- More code info
- —