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FDARecalled Dec 11, 2024 · #D-0105-2025

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Hazard

Class II — temporary health risk

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Description

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, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Type
Drugs
Manufacturer
Rising Pharma Holding, Inc.
Model numbers
DT2022023A
UPCs