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 recall2
BASG reference number INS - 640.001 - 1238

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