A drug used to reduce the risk of blood clots and strokes is being recalled after its manufacturer discovered higher levels of a substance in the medication that can increase the risk of cancer.
Ascend Laboratories has recalled 10 lots of Dabigatran Etexilate capsules because the medication has been found to have too much of the nitrosamine N-nitroso-dabigatran.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables,” the FDA-posted recall notice said. “Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” Ascend said in the release.
The recall includes two strengths of Dabigatran:
The recalled 75 mg capsules, NDC No. 67877-474-60, are lot Nos. 22142462, 22142463, and 22142464. The expiration date is May 2024.
For lot Nos. 221430000, 22143001 and 221430002, the expiration date is June 2024.
The recalled 150 mg strength capsules, NDC No. 67877-475-60, are lot Nos. 22142448, 22142449, and 22142450, the expiration date is May 2024. For 22143845, the expiration date is July 2024.
The recall notice advises consumers to continue taking the medication until a healthcare provider authorizes a different treatment.
For questions about the recall, call Ascend at 877-272-7901.
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