Further recall of pharmaceutical product by Novartis
17 Nov 2010
Further to the recall of three methotrexate injection preparations announced on November 15, the licensed drug wholesaler Novartis Pharm (HK) Ltd (Novartis) initiated a further recall of another methotrexate injection preparation from the local market today, as further investigation revealed that this product was also supplied in vials made of the same glass material as the earlier products. Glass particulates was also found in some vials of this product during routine stability tests.
Preliminary findings suggested that the glass particulates were apparently formed because of delamination of the inner glass surface of the vial as a result of reaction of the product’s solution with glass vials made of clear glass tubing over time.
The product concerned is Methotrexat-Ebewe Inj 10mg/ml Vial (Registration No. HK-39231), manufactured in Austria by Ebewe Pharma.
So far, no report of injury or adverse event related to this incident has been received.
While DH endorsed the recall and instructed Novartis to cease further distribution of the product as a matter of prudence, investigation continues and the recall will be closely monitored.
So far, there is no evidence to suggest that this phenomenon occurred in the remaining methotrexate injection preparation (a 5000 mg vial preparation) marketed by Novartis which is supplied in vials made of a different glass material. DH's investigation will continue.
Methotrexate is a prescription medicine, used for treatment of malignant tumours and serious psoriasis.
The product was mainly supplied to public and private hospitals, and private medical practitioners.
Novartis has set up a hotline (2881 5811) for enquiries during office hours.
Patients who feel unwell or have doubts after using the above product should consult his healthcare professional as soon as possible.