Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laborator...
FDA Recall #D-0129-2025 — Class II — December 12, 2024
Product Description
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Reason for Recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Recalling Firm
Ascend Laboratories, LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1971 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated