FDA-Drug2024-10-02Class II

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.

Ascend Laboratories, LLC
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA and PR
Affected count
117,493 bottles
Manufactured in
339 Jefferson Rd Ste 101, Parsippany, NJ, United States
Products
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.

Official notice

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

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