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Health alert: they withdraw a well-known medication for osteoporosis

The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market of a drug with alendronic acid/cholecalciferol that is used to treat osteoporosis, a disease characterized by a decrease in bone density due to loss of bone tissue. Specifically, the body dependent on the Ministry of Health has proceeded to withdraw from the market the affected batches “due to the out-of-specification results in the cholecalciferol assessment test.”

Specifically, the AEMPS notice affects the following batches manufactured by PHARMATHEN INTERNATIONAL SA:

ALENDRONIC ACID/CHOLECALCIFEROL WEEKLY ARISTO 70 MG/2,800 IU EFG TABLETS, 4 tablets (NR: 82792, CN: 720437)

Lot: 1008212, expiration date 06/30/2022

ALENDRONIC ACID/CHOLECALCIFEROL ARISTO 70 MG/5,600 IU EFG TABLETS, 4 tablets (NR: 82793, CN: 720439)

Lot: 1008320, expiration date 07/31/2022

Lot: 1106001, expiration date 04/30/2023

Health has proceeded to withdraw from the market all the distributed units of the affected batches and return them to the laboratory through the usual channels.