FDARecalled Jan 15, 2025 · #D-0190-2025
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Hazard
Class II — temporary health risk
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CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Classification: Class II Distribution: Nationwide
Product details
- Product
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Type
- Drugs
- Manufacturer
- Rising Pharma Holding, Inc.
- Model numbers
- —
- UPCs
- —