Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

Recall date

January 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04…

Recall number

D-0212-2025

FDA classification

Class II

Brand / firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.