Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured...

FDA Recall #D-0451-2022 — Class II — December 20, 2021

Recall #D-0451-2022 Date: December 20, 2021 Classification: Class II Status: Terminated

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

Recalling Firm

American Health Packaging — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

6,637 500-count bottles

Distribution

Nationwide in the USA

Code Information

Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated