FDA-Drug2025-08-20Class II
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Ascend Laboratories, LLC
Hazard
Failed Dissolution Specifications: low dissolution results
Sold states
Nationwide in the USA
Affected count
8,568 bottles
Manufactured in
135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
Products
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2025Don't want to check this manually?
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