Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. 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.
The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.
The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are indicated in the table below. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022.
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