Dabigatran Etexilate recalled over manufacturing violations

Recall date

December 12, 2024

Source

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

Official notice title

Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distr…

Recall number

D-0130-2025

FDA classification

Class II

Brand / firm

Ascend Laboratories, LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations: Presence of N-nitroso-Dabigatran 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

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60