Another drug recall is in effect due to high levels of a cancer-causing impurity known as nitrosamine.
This time, at the request of the FDA, Ascend Laboratories LLC. is voluntarily recalling lots of the blood thinner, Dabigatran Etexilate Capsules.
Some Dabigatran Etexilate Capsules may contain levels of a nitrosamine impurity — N-nitroso-dabigatran — that is above what is considered the acceptable daily limit.
Nitrosamines can be found in water and foods, including cured and grilled meats and dairy products. There is a connection between cooking some foods at high heat levels and nitrosamines.
However, these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
In the last couple of years, there have been previous recalls due to unacceptable levels of nitrosamines…
In March of 2022, Pfizer performed a voluntary recall for blood pressure medication.
And in December of 2023, Lupin Pharmaceuticals Inc. also issued a voluntary recall for a blood pressure-lowering drug.
As of today, Ascend Laboratories LLC. has not received reports of adverse events.
Is your medication in the drug recall?
Dabigatran Etexilate Capsules is used as an oral anticoagulant to lower the risk of stroke and blood clots.
In all, 10 lots of the drug have been recalled. You can view the entire list here.
Pharmacies, wholesalers and distributors have received the list of affected lots and have been advised to stop use and distribution and to quarantine the product immediately.
If you take this medication, your pharmacist should be able to help you discover if your current prescription is on the recall list.
What should you do?
They are advising that patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg to continue taking their medication and contact their physician for advice regarding an alternative treatment.
Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 7 days a week.
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail, by fax or by calling 1-800-332-1088 to request a reporting form.
Source:
Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity — U.S. Food & Drug Administration