Medicine recalls
|
| |
| Batch recall of Port Delivery System with Ranibizumab |
| |
The Department of Health (DH) today (17 Oct) endorsed a licensed wholesaler, Roche Hong Kong Limited (Roche), to recall two batches (batch number 1171684S04 and 1171684S07) of investigational medicinal product "Port Delivery System with Ranibizumab" due to a potential quality defect of the product.
The DH received notification from Roche that its headquarter in Switzerland initiated recall of the product due to the Port Delivery System not meeting the specifications of intended use. Septum dislodgement was noted in the Port Delivery System which was considered as a defect of the product. As a precautionary measure, Roche voluntarily recall the affected batches. DH's investigation is continuing.
The above product, containing Ranibizumab, is a prescription medicine under clinical trial for the treatment of macular degeneration. According to Roche, the affected batches have been supplied to two HA hospitals for clinical trial purpose.
So far, the DH has not received any adverse drug reaction report related to the affected product.
Roche has set up a hotline 9737 7495 to answer related enquiries. The DH will closely monitor the recall.
End/ 17 Oct 2022
|
| |
