Ascend Laboratories recalls 150mg Dabigatran Etexilate capsules (NDC 67877-475-60) due to detected N-nitroso-dabigatran impurities exceeding safety limits. Affected lots expire May 2024 or July 2024.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules that were manufactured with N-nitroso-dabigatran impurities above safe levels. This could cause serious health risks if taken as prescribed.
The capsules contained N-nitroso-dabigatran impurities at levels above the acceptable daily intake limit. This impurity could potentially cause serious health effects when taken as prescribed.
Prescription drug users who purchased the specific lots of Dabigatran Etexilate capsules from Ascend Laboratories in the US. People taking blood thinners are most at risk.
Check for the product name 'Dabigigatran Etexilate 150mg Capsules', 60-count bottles, and lot numbers 22142448-22142450 (expiring May 2024) or 22143845 (expiring July 2024).
Look for the lot numbers 22142448-22142450 (expiring May 2024) or 22143845 (expiring July 2024) on the bottle.
The official recall notice states the product contains impurities above safe levels, but does not specify if it's safe to use.
The recall notice does not provide specific action steps for affected products.
Check the lot numbers on the bottle: 22142448-22142450 (expiring May 2024) or 22143845 (expiring July 2024).
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0534-2023 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0534-2023 from Ascend Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
