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The Department of Health (DH) today (August 3) endorsed the recall of three batches of Thymoglobuline for IV Injection 25mg/5ml (Registration number: HK-33039) from the market by a licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited (Sanofi), because of a stability issue.
A DH spokesman said that Sanofi informed the DH today of a global recall of certain batches of Thymoglobuline on precautionary grounds. During an ongoing stability study, the French manufacturer, Genzyme Polyclonals SAS, found that one batch (No. CC0072) of the product failed to meet the specifications. This batch was only sold in the US.
As a precautionary measure, Genzyme initiated a global recall of all batches manufactured under the same conditions as those of the failed batch. According to the findings of Genzyme so far, none of the other batches failed to meet the specifications. 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.
The DH has requested Sanofi to provide a detailed investigation report on the cause of the incident. The DH's investigation is continuing.
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. The 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.
Ends/Friday, August 3, 2012
Issued at HKT 19:32
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