Reported Apr 5, 2023 · Ongoing
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, 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 Capsules, 75 mg, Rx Only, 60 Capsules per bottle
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60
- Lot codes and dates
Lot #s: 221424622214246322142464Exp 5/2024221430002214300122143002Exp 6/2024
- Amount recalled
- 13,560 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: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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