Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC ...

FDA Recall #D-0269-2023 — Class II — January 11, 2023

Recall #D-0269-2023 Date: January 11, 2023 Classification: Class II Status: Terminated

Product Description

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

Reason for Recall

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Recalling Firm

Amerisource Health Services LLC — Columbus, OH

Classification

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

Product Type

Drugs

Product Quantity

(a) 6670 100-count (b) 2666 500-count bottles

Distribution

Nationwide USA

Code Information

Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated