Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

Recall Number: D-0129-2025

Firm: Ascend Laboratories, LLC

Classification: Class II

Status: Ongoing

Report Date: 20241218

Initiation Date: 20241212

Termination Date:

Reason for Recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Product Description

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

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Data source: openFDA · Updated regularly