Class IIOngoing

Mycophenolic Acid Delayed-Release Tablets USP recall

FDA recall D-0668-2024 · initiated Sep 3, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Dissolution Specifications

Details

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.
Recalling company: Ascend Laboratories, Ltd
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA and PR
Initiated: Sep 3, 2024
FDA report date: Oct 2, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0668-2024 ↗

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