PlainRecalls
FDA Drug Moderate Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP 25 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 67877-590-01.

Reported: February 1, 2023 Initiated: January 5, 2023 #D-0169-2023

Product Description

Metoprolol Succinate Extended-Release Tablets, USP 25 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 67877-590-01.

Reason for Recall

Failed Dissolution Specification

Details

Recalling Firm
Ascend Laboratories, LLC
Units Affected
49,632 bottles
Distribution
Nationwide and Puerto Rico
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Metoprolol Succinate Extended-Release Tablets, USP 25 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 67877-590-01.. Recalled by Ascend Laboratories, LLC. Units affected: 49,632 bottles.
Why was this product recalled?
Failed Dissolution Specification
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2023. Severity: Moderate. Recall number: D-0169-2023.