United StatesDabigatran etexilate Capsules 110 mg (60-count carton, 6x10, NDC 0904-7254-68) lot 25141707 exp 4/30/2027 and 150 mg (20-count carton, 2x10, NDC 0904-7255-10) lot 25141584 exp 4/30/2027, manufactured by Alkem Laboratories (Mumbai, India) and distributed by Major Pharmaceuticals, are being recalled by Ascend Laboratories, LLC nationwide in the USA. The products were recalled after out-of-specification results were observed for related substance testing (Impurity II, Impurity III and total impurity) during 12-month long-term stability testing.
What's being recalled
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
Lot: 25141707, Exp 4/30/2027. Lot: 25141584, Exp 4/30/2027.
The hazard
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term 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)