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Recall 2 batches of Torisel Inj 25mg/ml

  • 2014.10.09

The Department of Health (DH) today (October 9) endorsed a licensed drug wholesaler, Pfizer Corporation Hong Kong Limited (Pfizer), to voluntary recall two batches of Torisel Inj Kit 25mg/ml (registration number: HK-58079) from the market due to potential quality issue. The affected batches were AIEM/1G and AI3V/1V. 

The DH received notification from Pfizer that the company has received complaints in overseas that particulate matters were observed in some of the diluent of the product. According to Pfizer, preliminary investigation indicated that the particulate matters were impurities of the diluent and only two batches of the product were affected. Since the particulate matters would dissolve in room temperature and filter would be applied during administration of the product, risk posed by the issue is considered to be minimal. Nevertheless, as a precautionary measure, Pfizer decided to recall globally the two affected batches. 

So far, the DH has not received any adverse reports in connection with the product. Investigation is continuing. 

Torisel Inj Kit 25mg/ml, containing temsirolimus, is a prescription medicine used for the treatment of advanced renal cells carcinoma. According to Pfizer, about 250 sets of the affected batches had been supplied to Hospital Authority, private hospitals, private doctors and pharmacies. 

Pfizer has set up a hotline on 2235 3245 to answer related enquiries. The DH will closely monitor the recall.