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FDARecalled Dec 11, 2024 · #D-0106-2025

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma H...

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, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Type
Drugs
Manufacturer
Rising Pharma Holding, Inc.
Model numbers
UPCs