Burinex
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 recall | 2 |
| BASG reference number | INS - 640.001 - 1239 |
Further inquiry note
Page last modified:
12/07/2022