Recall: D-0129-2025

Class II - Potentially Harmful

Class IIClassification

2024-12-12Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

Product

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

Reason

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.