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Beta-Blocker Recalled
Amerisource Health Services is voluntarily recalling 3 lots of metoprolol succinate extended-release tablets, manufactured by Alkem Laboratories Ltd, India, for failing to meet dissolution specifications.
“This recall is being initiated in support of the recall by the manufacturer, which included lots that were packaged for BluePoint Laboratories,” the February 22, 2022, US Food and Drug Administration (FDA) Enforcement Report explained.
The recalls affect the following products, which were distributed throughout the United States:
- metoprolol succinate extended-release tablets, 50 mg, packaged in 100-count bottles (NDC 68001-501-00), from lot 21143211 (Exp 3/31/23), and
- metoprolol succinate extended-release tablets, 50 mg, packaged in 500-count bottles (NDC 68001-501-03), from lots 21143185 and 21143193 (Exp 2/28/23).
American Health Packaging initiated the recall January 11, 2023. On February 15, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Metoprolol succinate is a prescription beta-blocker used to treat chest pain, heart failure, and high blood pressure.