American Health Packaging: Drug Recall

Recall #D-0451-2022 · 12/20/2021

Class II: Risk

Recall Details

Recall Number: D-0451-2022
Classification: Class II
Product Type: Drug
Recalling Firm: American Health Packaging
Status: Terminated
Date Initiated: 12/20/2021
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,637 500-count bottles

Reason for Recall

Failed Dissolution Specifications

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

Distribution Pattern

Nationwide in the USA

Other Recalls by American Health Packaging

Class III: Low Risk 05/03/2022

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III: Low Risk 04/12/2022

Subpotent Drug: Out of specification for assay.
Class II: Risk 02/22/2022

Impurity failure at 0-time of the repackaged lot.
Class II: Risk 09/17/2021

Failed Dissolution Specifications: results were above specification.
Class II: Risk 09/15/2021

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

View all recalls by American Health Packaging →

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.