Poland recalls Concor 5 mg hypertension tablets over nitrosamine contamination

Poland's chief drug regulator, the Główny Inspektorat Farmaceutyczny (GIF), ordered an immediate, nationwide withdrawal of Concor 5 mg and Concor Cor 5 mg tablets after testing revealed the presence of the nitrosamine N‑Nitroso‑Bisoprolol (NBP) above the permissible limit. The contamination affected specific batches produced between November 2022 and September 2023 by Merck, as well as parallel‑imported batches from Bulgaria (Medezin) and Spain (InPharm). The auxiliary substance supplied by an alternate vendor was identified as the source, and that supplier has been excluded from production.

Patients holding any of the listed batch numbers are advised to stop using the medication, consult their physician or pharmacist, and return the tablets to the pharmacy for a safe replacement. GIF has published the full batch list on its website and emphasizes that the recalled products do not meet quality specifications, posing an unacceptable health risk.