FDA recall D-0129-2025

Ascend Laboratories, LLC · Class II · drug

Product

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

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2024-12-12
Report date: 2024-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0129-2025