FDA DrugClass IINotable

FDA Recall: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutica

Date: 2026-05-13
Brand: Breckenridge Pharmaceutical, Inc.
Category: Drug
FDA Class: Class II

Description

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Hazard

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Remedy

165,761 90-count bottles

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