AmBisome
Recall
|
Medicines
|
20/06/2013
The marketing authorization holder has informed its supplied customers in a letter dated June 19, 2013, that due to a manufacturing problem and the associated risk of microbial contamination with "Sphingomonas yanoikuyae", the above mentioned batches 042265AD, 042285AD, 042304AD1 are being recalled as a precautionary measure. The information letter on the batch recall is only being sent to the pharmacies and wholesalers supplied due to the small distribution circle.
| Name of the medicinal product | AmBisome 50 mg-Pulver zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | 1–20606 |
| Marketing authorisation holder | Gilead Sciences International Ltd, UK Durchführung des Rückrufes in Österreich: GILEAD Sciences GesmbH Wagramerstraße 19 1220 Wien |
| Batch number(s) | 042265AD, 042285AD, 042304AD1 |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-0799 |
Further inquiry note
Page last modified:
12/07/2022