The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
Ascend Laboratories is recalling 10 lots of Dabigatran Etcxilate capsules 75 mg and 150 mg because of the presence of a nitrosamine, N-nitroso-dabigatran, above acceptable limits. Dabigatran is used as an oral anticoagulant to lower the risk of stroke and blood clots.
Nitrosamines are common in water and foods but exposure above limits increases the risk of cancer. To date, Ascend Laboratories has not received any reports of adverse events related to this recall.
Ascend’s product is a generic of Boehringer Ingelheim’s Pradaxa.
The product lots were distributed nationwide to wholesalers, distributors and retailers in the United States from June 2022 to October 2022. The expiration dates are from May 2024 to July 2024. A list of the lot and NDC numbers can be found here.