dabigatran etexilate
2 recalls on record
A
Ascend Laboratories, LLC — Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 070
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
FDAHealth
A
Ascend Laboratories, LLC — Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 070
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
FDAHealth