US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 14, 2023 (3 years ago)

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

What was recalled

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

Recalling firm
Ascend Laboratories, LLC
NDC code
67877-475-60
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0534-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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