Medicine recalls
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| Further Recall of Dotarem Injection 377mg／ml (10 ml vial) |
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Further to the announcement on the recall of a batch (batch number: 21GD054A) of Dotarem Injection 377 mg/ml on 12 November 2021, the Department of Health (DH) today (22 November) endorsed the licensed drug wholesaler, Guerbet Asia Pacific Limited (Guerbet), to further recall another four batches (batch number: 20GD075A, 20GD075B, 20GD075C, 20GD080A) 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.
According to notification from Guerbet, overseas manufacturer of the above product has noticed defects in other lots of glass containers of the above product after further assessment. As a result, the manufacturer decided to recall related affected batches of finished products as quality of them may be affected. According to Guerbet, the additional four batches have been imported and supplied in Hong Kong. As a precautionary measure, Guerbet is voluntarily recalling these batches 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 additional 4 batches have been supplied to private hospitals and private doctors in Hong Kong as well as exported to eight Asian countries. Guerbet has informed these parties about the recall.
So far, the DH has not received any adverse reaction reports in connection with these batches 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.
Related recall message of the same product issued by the Drug Office on 12 November 2021 is attached below.
Related Information:
Batch Recall of Dotarem Injection 377mg／ml (10 ml vial) Posted on 12 November 2021
http://www.drugoffice.gov.hk/eps/news/../45782.html
Ends/Monday, 22 November, 2021
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