Recall D-0668-2024

US Class II Ongoing · initiated 2024-09-03

Recalling firm

Ascend Laboratories, LLC, NJ

Product

Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.

Reason for recall

Failed Dissolution Specifications

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