Press Release

Batch recall of Thymoglobuline for IV Injection 25mg/5ml

3 August 2012

The Department of Health (DH) today (August 3) endorsed the recall of three batches of Thymoglobuline for IV Injection 25mg/5ml (Thymoglobuline) (Registration number: HK-33039) from the market by a licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited (Sanofi) because of stability issue.

A DH spokesman said that Sanofi informed DH today of a global recall of certain batches of Thymoglobuline on precautionary ground. During ongoing stability study, the French manufacturer, Genzyme Polyclonals S.A.S., (Genzyme) found that one batch (No. CC0072) of the product failed the specification. This batch was only sold in the US.

As a precautionary measure, Genzyme initiated a global recall of all batches manufactured under the same condition of the failed batch. According to the finding of Genzyme so far, none of the other batches failed the specification. Only three of the recalled batches had been imported into Hong Kong. The batch numbers are C0074H29, C0088H10 and C0102H03.

The three batches had been supplied to the Hospital Authority and some vials of one batch (C0074H29) were exported to Macau.

DH has requested Sanofi to provide a detail investigation report of the cause of incident. The DH's investigation continues.

Thymoglobuline is indicated for the prophylaxis and treatment of graft rejection in transplantation. It can only be sold on prescription and under the supervision of pharmacists at registered dispensaries.

The DH has not received any adverse report in connection with the product.

Sanofi has set up a hotline at 9316 7212 to answer related enquiries. DH will closely monitor the recall.

"Members of the public who have been given the product should consult their health-care providers if in doubt or feeling unwell," the DH spokesman said.