Torisel
Recall
|
Medicines
|
13/10/2014
In a letter dated October 8, 2014, the distribution company informed its supplied customers that there is a possibility of crystals forming if the enclosed diluent of batch AHZW/1 is stored at 2 to 8°C. The diluent was used for the production of this diluent batch. The observed crystals are probably impurities of a polysorbate (Tween) 80 batch used for the production of this diluent batch. The affected diluent batch was again packaged in the two finished product batches listed above, therefore a voluntary recall was issued.
| Name of the medicinal product | Torisel 30 mg Konzentrat und Verdünnungsmittel zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/07/424/001 |
| Marketing authorisation holder | Pfizer Limited Vertrieb und Durchführung Rückruf: Pfizer Corporation Austria Ges. m.b.H. |
| Batch number(s) | AIEM / 1 A, AIIM /1Z |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1238 |
Further inquiry note
Page last modified:
12/07/2022