Class IIReported 2025-02-05

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason for Recall

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Recall Number

D-0212-2025

Classification

Class II

Status

Terminated