Blood thinner recalled after failed test
The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling specific lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. This is a generic version of a popular direct oral anticoagulant (DOAC) most commonly sold by Boehringer Ingelheim under the brand name Pradaxa.
The recall was put in place due to a failed impurity/degradation test. After 12 months, the drug produced an out-of-specification (OOS) test result.
More than 5,000 cartons of dabigatran etexilate capsules are included in this recall. One lot contains blister packs of 60 150-mg capsules. The other lots contain blister backs of 30 or 60 75-mg capsules. All capsules are set to expire in April 2027.
No other lots of dabigatran etexilate capsules, including any sold by Boehringer Ingelheim, are a part of this recall.
New Jersey-based Ascend Laboratories is a wholly owned subsidiary of Alkem Laboratories, the Indian pharmaceutical company that manufactured the recalled pills. Meanwhile, Indianapolis-based Major Pharmaceuticals is the company that distributed the affected lots to U.S. customers.
The FDA is still investigating this issue. Click here for additional details from the agency.
A similar recall occurred in 2023
Back in March 2023, Ascend Laboratories recalled certain lots of this same DOAC due to unacceptable levels of N-nitrosodimethylamine (NDMA). NDMA is a contaminant commonly found in trace amounts in water and various foods. Too much exposure to this impurity, however, is associated with a heightened cancer risk.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.