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Beta-Blocker Recalled
Ascend Laboratories is recalling 58,596 bottles of metoprolol succinate extended-release tablets for failing to meet dissolution specifications, according to the February 1, 2023, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Alkem Laboratories Ltd, Mumbai, India, and distributed Ascend Laboratories, Parsippany, New Jersey, throughout the United States and in Puerto Rico:
- metoprolol succinate extended-release tablets, 25 mg, 100-tablet bottles (NDC 67877-590-01), from lots 21143094, 21143095, 21143119, 21143121, and 21142389 (Exp. 3/31/23);
- metoprolol succinate extended-release tablets, 50 mg, 100-tablet bottles (NDC 67877-591-01), from lot 21142633 (Exp. 3/31/23); and
- metoprolol succinate extended-release tablets, 50 mg, 500-tablet bottles (NDC 67877-591-05), from lots 21141321 and 21141322 (Exp. 1/31/23).
Ascend Laboratories voluntarily initiated the recall January 5, 2023. On January 20, 2023, the FDA designated the recall Class II, signaling use of the recalled 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.