Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri
Recalled December 18, 2024 · FDA recall D-0130-2025 · Ascend Laboratories
Hazard
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit · FDA Class II
Units
10,444 bottles
Sold at
Nationwide within the United States
Description
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Product
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
Manufacturer(s)
Ascend Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →