Two batches of osteoporosis drugs withdrawn from market

“Out of specification results” detected

Portugal’s medicines agency Infarmed has announced the recall of two batches of Alendronic Acid + Colecalciferol Aristo because “results outside the specifications were detected for the substance Cholecalciterol”.

THE voluntary collection of the two lots will be carried out by the company Aristo Pharma GmbH and Infarmed has ordered the “immediate suspension of distribution” of the batches which it has described as “5717343 – 4 tablets Alendronic Acid + Colecalciferol Aristo 70 mg + 5600 IU 1106052 04/2023” and “5717327- 4 tablets Alendronic Acid + Colecalciferol Aristo 70 mg + 2800 IU 1106669 04/2023”.

According to Infarmed’s note, “entities that have these batches of medicine in stock cannot sell, dispense or administer them, and must return them“.

Anyone prescribed these medications and using them should not stop, but needs to get in touch with their doctor in order to be prescribed an alternative.

Spain has made a similar recall, albeit 10 days ago.

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