Home / Recalls / Ascend Laboratories, LLC / D-0129-2025

D-0129-2025 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
December 18, 2024
Initiation Date
December 12, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1971 bottles

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.

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