Reported Dec 18, 2024 · Ongoing
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA,…
Ascend Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
- Lot codes and dates
Lot #: 241421922414219324142194Exp. Date April 30202624142463Exp. Date May 312026
- Amount recalled
- 10,444 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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