Health alert: Spain recalls a well-known osteoporosis drug

The Spanish Medicines Agency warns of "out-of-specification results” in assessment tests

ALMUDENA NOGUÉS

The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal from the market of a drug containing alendronic acid / colecalciferol used to treat osteoporosis, a disease characterised by decreased bone density due to loss of bone tissue.

Specifically, the authority has recalled batches of the affected drugs "due to the results out of specifications in the assessment test for cholecalciferol".

The health alert notice affects the following batches manufactured by PHARMATHEN INTERNATIONAL SA:

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

Lot: 1008212, expiry date 06/30/2022

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

Lot: 1008320, expiry date 07/31/2022

Lot: 1106001, expiry date 04/30/2023

The Ministry of Health has started the withdrawal of all the distributed units of the affected batches from the market and urged anyone in possession of them to return them to the manufacturing laboratory through the usual channels.