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Ascend Laboratories, LLC recalls Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratori

Recalled October 2, 2024 · FDA recall D-0668-2024 · Ascend Laboratories

Hazard
Failed Dissolution Specifications · FDA Class II
Units
117,493 bottles
Sold at
Nationwide in the USA and PR

Description

Failed Dissolution Specifications

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.
Manufacturer(s)
Ascend Laboratories, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov