FDA DrugClass IINotable

FDA Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Tow

Date: 2026-06-17
Brand: Breckenridge Pharmaceutical, Inc.
Category: Drug
FDA Class: Class II

Description

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Hazard

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Remedy

14,729 bottles.

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