United StatesAmlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg, 30 tablets per bottle (NDC 67877-500-30), lot 25121311, expiry 3/31/2028, manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC, is being recalled. The product failed dissolution specifications and olmesartan medoxomil content was below specifications.
What's being recalled
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
Lot 25121311, expiry 3/31/2028
The hazard
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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
Nationwide in the USA
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)