D-0170-2023 Class II Terminated

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

FDA drug recall D-0170-2023 was initiated by Ascend Laboratories, LLC on January 5, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specification The recall status is terminated (terminated August 15, 2024). Affected quantity: 6,336 bottles.

Recall Details

Product Type
Drugs
Report Date
February 1, 2023
Initiation Date
January 5, 2023
Termination Date
August 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,336 bottles

Product Description

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.

Reason for Recall

Failed Dissolution Specification

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 21142633, Exp 03/31/2023