Batch recall of Nucala Solution for Injection in Pre-filled Pen 100mg/ml (with photo)


     The Department of Health (DH) today (July 8) endorsed a licensed drug wholesaler, GlaxoSmithKline Limited (GSK), to recall a batch (batch number: 3K4D) of Nucala Solution for Injection in Pre-filled Pen 100mg/ml (Hong Kong Registration Number: HK-66838) from the market as a precautionary measure due to a potential quality defect of the product.

     The DH received notification from GSK today that a fibre was found in one of the finished products which is a quality defect. After assessment, the overseas manufacturer believes that the defect may be originated from a bulk product batch which may affect a number of finished product batches. As a result, the manufacturer decided to recall all the finished product batches. According to GSK, the batch 3K4D is the only affected batch which has been imported and supplied in Hong Kong. As a precautionary measure, GSK is voluntarily recalling the batch from the market.

     The above product is a prescription medicine used for the treatment of severe asthma. According to GSK, the affected batch has been supplied to Hospital Authority, private hospitals and private doctors.

     GSK has set up a hotline (3189 8765) to handle related enquiries.

     “So far, the DH has not received any adverse reaction reports in connection with the batch of product. The DH will closely monitor the recall,” a spokesman for the DH said.

     ​”Patients who are using the above product should not stop using the medicine, but should seek advice from their healthcare professionals for appropriate arrangement,” the spokesman added.