Thioguanin "Aspen"

Replacement | Medicines | 29/04/2011

In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability were outside the specification.

Name of the medicinal product Thioguanin "Aspen“ – Tabletten / Thioguanin "GSK“ – Tabletten
Marketing authorisation number(s) 16.354
Marketing authorisation holder Aspen Europe GmbH (vor 08/2010: GlaxoSmithKline Pharma GmbH)
Batch number(s) 905066, 907324
Classification of the recallII
BASG reference number INS-640.001-0108

Further inquiry note