Recall | Medicines | 21/07/2016

The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This medicinal product is placed on the market in Austria within the scope of a transfer notification pursuant to the Austrian Medicinal Products Import Act 2010.

Name of the medicinal product Thromboreductin 1,0 mg Kapseln
Marketing authorisation number(s) Nicht bekannt, im Ausland zugelassene Arzneispezialität
Marketing authorisation holder AOP Orphan Pharmaceuticals AG
Batch number(s) E316A
Classification of the recall2
BASG reference number INS - 640.001 - 1785

Further inquiry note