Ascend Laboratories, LLC: Drug Recall

Recall #D-0668-2024 · 09/03/2024

Class II: Risk

Recall Details

Recall Number
D-0668-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Ascend Laboratories, LLC
Status
Ongoing
Date Initiated
09/03/2024
Location
Parsippany, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117,493 bottles

Reason for Recall

Failed Dissolution Specifications

Product Description

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.

Distribution Pattern

Nationwide in the USA and PR

Other Recalls by Ascend Laboratories, LLC

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.