Duloxetine Delayed-Release Capsules recalled over manufacturing violations

Recall date

December 2, 2024

Source

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

Official notice title

RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 705…

Recall number

D-0165-2025

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

Nationwide in the US

Why it was recalled

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim 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, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA