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Press Release

Recall of three methotrexate injection preparations

15 Nov 2010

The Department of Health (DH) received notification from a licensed drug wholesaler, Novartis Pharm (HK) Ltd (Novartis), today (November 15) that it had initiated recall of three methotrexate injection preparations from the local market because glass particulates were found in some vials.

The products to be recalled are -
a) Methotrexat-Ebewe Inj 50mg/5ml Vial (Registration No: HK-37639);
b) Methotrexat-Ebewe Inj 500mg Vial (Registration No: HK-38794); and
c) Methotrexat-Ebewe Inj 1000mg/10ml Vial (Registration No: HK-39232).

They are all manufactured in Austria by Ebewe Pharma.

While DH endorsed the recall and instructed Novartis to cease further distribution of the products as a matter of prudence, investigation to the cause was also launched immediately.

Methotrexate is a prescription medicine, used for treatment of malignant tumours and serious psoriasis.

The products were mainly supplied to public hospitals, private hospitals and private practitioners.

Preliminary findings suggested that the glass particulates were apparently formed because of delamination of the inner glass surface of the vials as a result of reaction of the products' solution and glass over time.

Novartis has set up a hotline (2881 5811) for enquiries during office hours.

If any patient who has received any of the above products has any doubt or feels unwell, they should consult their healthcare workers as soon as possible.

The DH's investigation continues.

Three methotrexate injection preparations on recall.

  Last Revision Date : 15 November 2010