Ascend Laboratories, LLC 2023-04-05 Health serious FDA
Health · FDA · Recall #FDA-D-0534-2023
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,… Recall
Issued April 5, 2023 · Ascend Laboratories, LLC
In April 2023, Ascend Laboratories, LLC recalled the Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
What you should do
- 1 Stop using Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ascend Laboratories, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ascend Laboratories, LLC
- Category
- Health
- Recall date
- April 5, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA.
- Recall number
- FDA-D-0534-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Ascend Laboratories, LLC has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.