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Blood Thinner Recalled Over Cancer-Causing Impurity

Nitrosamine, a carcinogen, detected in batches

spinner image logo for pharmaceutical company Acsend Laboratories along with a rendering of red blood cells moving through an artery
Acsend Laboratories, LLC / Getty Images

A cancer-causing impurity has been found in several lots of a blood thinning medication used to lower the risk of stroke and blood clots, the Food and Drug Administration announced in a statement.

A nitrosamine called N-nitroso-dabigatran was found in 75 mg and 150 mg capsules of  dabigatran etexilate at levels exceeding the FDA’s established acceptable daily limit. The drug was distributed nationwide by Ascend Laboratories.

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Nitrosamines are present in water and foods such as cured and grilled meats, dairy products and vegetables. Although everyone is exposed to some level of nitrosamines, the FDA set an internationally recognized acceptable daily intake limit for the impurity. The agency recommends that drugs containing levels above the acceptable daily intake limit be recalled as appropriate.​

Although nitrosamines can increase the risk of cancer if consumed above acceptable levels over a long period of time, taking a drug that contains nitrosamines at or below the acceptable limit daily for 70 years is not expected to increase cancer risk, according to the FDA.

Recalled Medications

The recalled 150 mg and 75 mg dabigatran etexilate mesylate capsules were distributed from June to October 2022 and have an expiration date of May 2024 or June 2024. The national drug code is 67877-475-60. The following lots are affected: 22142448, 22142449, 22142450, 22142462, 22142463, 22142464, 22143000, 22143001, 22143002 and 22143845.

Advice to patients

Patients who have the recalled drugs are advised to continue taking their medication and contact their health care provider for advice regarding an alternative treatment. Meanwhile, pharmacies with existing inventory of these medications have been advised to stop distributing them.

Anyone with questions about this recall or with adverse events to report may contact Ascend Laboratories at 877-272-7901. The line is open 24 hours a day, seven days a week.

Negative reactions or quality problems may also be reported to the FDA’s MedWatch adverse event reporting program online, by phone at 800-332-1088 or by fax using this form to 800-FDA-0178.

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