Recall: D-0668-2024

Class II - Potentially Harmful

Class IIClassification

2024-09-03Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Failed Dissolution Specifications

Distribution

Nationwide in the USA and PR

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.