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Recall of Blood Thinner Due to Presence of Cancer-Inducing Contaminant

Drug recall issued over elevated levels of cancer-causing impurity nitrosamine in blood thinner Dabigatran, marking the third such incident in the past two years. Here's the critical information...

Warning issued over recalled blood thinner containing cancer-inducing contaminant
Warning issued over recalled blood thinner containing cancer-inducing contaminant

Recall of Blood Thinner Due to Presence of Cancer-Inducing Contaminant

In March 2023, Ascend Laboratories LLC voluntarily recalled several lots of Dabigatran Etexilate Capsules, an oral anticoagulant, at the request of the FDA. The recall was due to the detection of N-Nitrosodimethylamine (NDMA) impurity, a cancer-causing agent, in some lots of the drug.

The affected lots include both 75 mg and 150 mg strengths. Despite the recall, as of today, Ascend Laboratories LLC has not received reports of adverse events related to this recall.

Pharmacies, wholesalers, and distributors have been advised to stop use and distribution, and quarantine the product immediately. Customers with medical-related questions, adverse events, or quality issues about the recalled product should contact Ascend Laboratories LLC at 877-272-7901.

It is important to note that prolonged exposure to nitrosamines, including NDMA, may increase the risk of cancer. Nitrosamines can be found in water, cured and grilled meats, and dairy products, with levels increasing when foods are cooked at high heat.

However, in recent documentation and industry updates, no recalls or quality issues tied to nitrosamine impurities have been reported for Dabigatran Etexilate from Ascend Laboratories LLC. The FDA's MedWatch program can be reached online, by mail, by fax, or by calling 1-800-332-1088 to request a reporting form for any adverse reactions or quality problems experienced with the use of this product.

As of August 2025, no FDA or regulatory agency recalls or warnings related to Dabigatran Etexilate capsules from Ascend Laboratories LLC were found in the reviewed documents or databases. For the latest regulatory status, checking the FDA's official enforcement reports or the manufacturer’s announcements directly would be recommended.

  1. In the realm of health and wellness, it's crucial to understand that chronic diseases like type-2 diabetes and cancer may require supplements for proper management.
  2. To maintain optimal health, nutritious eating and mental-health therapies and treatments are equally important, especially when dealing with medical-conditions such as chronic diseases.
  3. Ascend Laboratories LLC, in the broader scientific community, has been involved in the production of Dabigatran Etexilate Capsules, a medication used to manage certain medical-conditions.
  4. Recently, Ascend Laboratories LLC voluntarily recalled several lots of Dabigatran Etexilate Capsules due to the detection of N-Nitrosodimethylamine (NDMA), a cancer-causing agent, in some lots of the drug.
  5. CBD, a compound derived from cannabis, has been gaining traction as a potential supplement for various health problems, but it's important to note that its effects, like those of any other supplement, should be discussed with a healthcare provider.

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