Recall | Medicines | 24/11/2017

The distribution partner for the marketing authorization holder, "DSD Pharma GmbH", informed its supplied customers in a letter dated November 15, 2017, that the qualified person for batch 171115FDG01 has not issued a batch release and that the batch in question may therefore not be used.

Name of the medicinal product [18F]Fludeoxyglucose Biont 200-2200 MBq/ml Injektionslösung
Marketing authorisation number(s) 4-00048
Marketing authorisation holder Biont a.s.

Vertrieb und Durchführung Rückruf:
DSD Pharma GmbH
Batch number(s) 171115FDG01
Classification of the recall3
BASG reference number INS-640.001-2346

Further inquiry note