Batch recall of Rocephin for INJ 1g IV Sterile Powder
[Hong Kong, 30 June 2022] The Department of Health (DH) today (June 30) endorsed Roche Hong Kong Limited (Roche) to recall a batch of Rocephin for INJ 1g IV Sterile Powder (Hong Kong Registration Number: HK-20190) from the market due to a potential quality defect of the product.
Pinhole defects have been detected in 10 mL Water for Injection (WFI) ampoules of the product . Upon assessment by the overseas manufacturing site, the defect rate is estimated to be 0.006%. There is one impacted batch (Batch number: B0746B02) that has been supplied to private hospitals and private doctors in the Hong Kong and Macau market. As a precautionary measure, Roche is initiating a voluntary recall of this batch of product.
Roche has set up a dedicated Recall hotline (+852 2895 9531) to handle related enquiries.
Roche will closely monitor the recall and report to DH. So far, Roche have not received any adverse reports in connection with the impacted batch.