Home › Prescription medicine › Ascend Laboratories, LLC — Dabigatran…
Ascend Laboratories, LLC — Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Ascend Laboratories, LLC
The product
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Details
- Units affected
- 1971 bottles
- Recall date
- December 12, 2024
- Brand
- Ascend Laboratories, LLC
Nationwide within the United States
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Ascend Laboratories, LLC — Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine