Ascend Laboratories, LLC is recalling approximately 26,364 bottles of Dabigatran Etexilate Capsules (75 mg and 150 mg), a medication used to prevent blood clots and strokes. This recall was initiated because testing detected levels of a nitrosamine impurity called N-nitroso-dabigatran (NDAB) that exceed the acceptable daily intake limit set by the FDA. Consumers using this medication should contact their healthcare provider or pharmacist to discuss their treatment before stopping the medication.
The recalled medication contains N-nitroso-dabigatran (NDAB), which is a type of nitrosamine. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure above certain levels may increase the risk of developing cancer.
You have 2 options:
Manufactured by Alkem Laboratories Ltd., INDIA; 60 Capsules per bottle.
Manufactured by Alkem Laboratories Ltd., INDIA; 60 Capsules per bottle.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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