FDA recall D-0668-2024

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

Distribution

Nationwide in the USA and PR

Key facts

Status

Ongoing

Initiation date

2024-09-03

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0668-2024