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The Department of Health (DH) today (July 2) endorsed the recall of one batch (imported as two sub-batches namely C1270H03 and C1270H18) 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 detected during routine testing.
The DH today received notification from Sanofi of a global recall of one batch (No. C1270) of Thymoglobuline for IV Injection 25mg/5ml because the product's manufacturer in France, Genzyme Polyclonals SAS, found that it fell out of specification in aggregation level during ongoing stability study.
According to Sanofi, a total of 365 vials of the affected batch of products were imported into Hong Kong as two sub-batches (No. C1270H03 and No. C1270H18). One hundred and twenty-six vials were supplied to the Hospital Authority (HA) and 50 vials of one sub-batch (No. C1270H03) were exported to Macau. All the remaining stock is kept in the wholesaler's warehouse. Sanofi has already informed the HA and the importer of Macau about the recall.
Thymoglobuline is an immune globulin indicated for the prophylaxis and treatment of graft rejection in transplantation. It is a prescription medicine and should only be used under medical advice. Although the elevated aggregation level may theoretically lead to an increased risk of immune reactions such as anaphylaxis and serum sickness, such risk is considered low.
So far, 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.
Ends/Tuesday, July 2, 2013
Issued at HKT 21:29
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