Replacement | Medicines | 30/05/2011

The marketing authorization holder informed its supplied customers in a letter dated May 26, 2011, that the degradation product prostaglandin A1 (PGA1) was above the specified limit at the end of the 24-month period and thus a replacement had to be carried out.

Name of the medicinal product Pridax 20 Mikrogramm/ml - Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) 1-22020
Marketing authorisation holder Gebro Pharma GmbH
Batch number(s) 20 Chargen:

9326022AT, 9446011AT, 9476081AT, 9536011AT, 1001021AT, 1004013AT, 1004062AT, 1006071AT, 1009012AT, 1009061AT, 1017091AT, 1024102AT, 1026011AT, 1026041AT, 1027071AT, 1036022AT, 1047061AT, 1052042AT, 042103, 043103
Classification of the recall2
BASG reference number INS-640.001-0141

Further inquiry note