Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules due to the presence of a NDSRI, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level

Nitrosamines in the News
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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg

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From Announcement it is not clear what is actually nitrosamine in question.
Heading and summary is mentioning NDMA while body of announcement says about N-nitroso-dabigatran. Has anybody clue?

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I think it’s Nitroso dabigatran. It looks like a transcription error from the FDA.

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It is clearly mentioned as N-Nitroso-dabigatran (NDAB) Impurity

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg

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hello:
They have corrected it. At first they copied and pasted NDMA…
Now it’s ok :smile:

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Right…It is corrected now

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