Recall | Medicines | 01/04/2016

The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration results from a production deviation and occurs after longer storage at room temperature.

Name of the medicinal product Noradrenalin Orpha 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) 1-31880
Marketing authorisation holder Orpha-Devel Handels und Vertriebs GmbH

Durchführung Rückruf:
Amomed Pharma GmbH
Batch number(s) 5A631A, 5A632A, 5A633A
Classification of the recall2
BASG reference number INS - 640.001 - 1 679

Further inquiry note