Recall | Medicines | 15/10/2014

The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as well as a change in the color of the solution were detected in stability tests, so that the affected batches are being recalled as a precautionary measure.

Name of the medicinal product Burinex "Leo" 2 mg -Ampullen
Marketing authorisation number(s) 1-18702
Marketing authorisation holder Leo Pharma A/S

Vertrieb und Durchführung Rückruf:
LEO Pharma Gesellschaft m.b.H
Batch number(s) F0004-1, F1005AT1, F1009AT1
Classification of the recall2
BASG reference number INS - 640.001 - 1239

Further inquiry note