United StatesDabigatran Etexilate Capsules — 150 mg (60-count 6x10 blister, NDC 0904-7255-68) and 75 mg (60-count 6x10, NDC 0904-7253-68; 30-count 3x10, NDC 0904-7253-04) manufactured by Alkem Laboratories Ltd., Mumbai and distributed by Major Pharmaceuticals, lots 25141583, 25141585, 25141586, exp. April 30, 2027, sold nationwide in the U.S. — are affected. They were recalled after out-of-specification results in related substance testing showed Impurity II, Impurity III and total impurities above specification at 12-month stability.
What's being recalled
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
Lot: 25141583, Exp. April 30, 2027. Lot: 25141585, Exp. April 30, 2027. Lot: 25141586, Exp. April 30, 2027.
The hazard
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)