Recall D-0576-2025

US Class II Ongoing · initiated 2025-07-21

Recalling firm

Ascend Laboratories, LLC, NJ

Product

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

Reason for recall

Failed Dissolution Specifications: low dissolution results

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