FDA-Drug2024-12-18Class II
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
Ascend Laboratories, LLC
Hazard
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Sold states
Nationwide within the United States
Affected count
10,444 bottles
Manufactured in
339 Jefferson Rd Ste 101, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2025Don't want to check this manually?
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