FDARecalled Jan 15, 2025 · #D-0188-2025
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
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 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
- Type
- Drugs
- Manufacturer
- Rising Pharma Holding, Inc.
- Model numbers
- DT3023051A
- UPCs
- —