Parsippany, New Jersey -based Ascend Laboratories LLC. is recalling Dabigatran Etcxilate capsules citing the detection of N-Nitrosodimethylamine or NDMA impurity, a probable human carcinogen, the U.S. Food and Drug Administration said.
The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.
The recall involves Dabigatran Etexilate Capsules, USP 75 mg and 150 mg to the consumer/user level with various lot numbers and expiration dates.
The affected product lots were distributed nationwide to wholesalers, Distributors and Retailers in the United States from June 2022 to October 2022.
The recall of the drugs to the consumer level from the US market was due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake or ADI level.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
However, Ascend Laboratories has not received any reports of adverse events related to this recall to date.
Wholesalers/distributors and pharmacies with an existing inventory of the lots are asked to stop use and distribution and quarantine the product immediately.
Wholesalers and Distributors are advised to recall the distributed product, and to immediately cease distribution of the affected product.
The agency noted that patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.
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