Medicine recalls
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| Batch Recall of Dotarem Injection 377mg／ml (10 ml vial) |
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The Department of Health (DH) today (12 November) endorsed a licensed drug wholesaler, Guerbet Asia Pacific Limited (Guerbet), to recall a batch (batch number: 21GD054A) of Dotarem Injection 377mg/ml (10ml vial) (Hong Kong Registration Number: HK-41578) from the market as a precautionary measure due to a potential quality defect of the product.
The DH received notification from Guerbet today indicating that the overseas manufacturer of the above product has noticed leakage of content in some finished products. The overseas manufacturer’s assessment showed that the leakage is caused by a defect of certain lots of glass container of the above product. As a result, the manufacturer decided to recall all the affected batches as quality of the above product may be affected. According to Guerbet, the batch 21GD054A is the only affected batch which has been imported and supplied in Hong Kong. As a precautionary measure, Guerbet is voluntarily recalling the batch from the market.
The above product is a diagnostic imaging agent as well as a prescription medicine used in magnetic resonance imaging (MRI) for diagnosis of diseases such as cerebral and spinal diseases. The DH noted that the concerned product is not a radioactive substance and would only be administered to patient receiving MRI at hospitals or clinics. According to Guerbet, the affected batch has been supplied to private hospitals and private doctors in Hong Kong as well as exported to Thailand. Guerbet has informed these parties about the recall.
So far, the DH has not received any adverse reaction reports in connection with the batch of product.
Guerbet has set up a hotline (2541 5731) to handle related enquiries. The DH will closely monitor the recall.
Health-care professionals who have the product in hand should return the product to the supplier.
Ends/Friday, 12 November, 2021
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