PlainRecalls
FDA Drug Moderate Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

Reported: February 2, 2022 Initiated: December 20, 2021 #D-0451-2022

Product Description

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
American Health Packaging
Units Affected
6,637 500-count bottles
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03. Recalled by American Health Packaging. Units affected: 6,637 500-count bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0451-2022.