Ascend Laboratories, LLC recall (Cls 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 — Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Status: Ongoing