Medicine recalls
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| Canada: Recall: Dotarem Injection - Product Sterility |
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Health Canada announces that Methapharm Inc. is recalling one lot of Dotarem Injection (Gadoterate Meglumine 376.9 mg/ml, equivalent to 0.5 mmol/ml; lot number: 20GD087B02) from healthcare establishments because product sterility may be compromised in the affected lot due to the possibility of defects in the vial.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/dotarem-injection-product-sterility
In Hong Kong, Dotarem Inj 377mg/ml (vial) (HK-41578) is a pharmaceutical product registered by Guerbet Asia Pacific Ltd (Guerbet) and is a prescription-only medicine. As confirmed with Guerbet, the above affected batch has not been imported into Hong Kong.
On 12 Nov 2021 and 22 Nov 2021, the Department of Health (DH) endorsed Guerbet to recall a total of 5 batches of Dotarem Inj 377mg/ml (10ml vial) (HK-41578) (batch number: 21GD054A, 20GD075A, 20GD075B, 20GD075C, 20GD080A) from the market as a precautionary measure due to potential quality defect of the product. Recall statements were issued on 12 Nov 2021 and 22 Nov 2021 respectively.
Related news was previously issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and was posted on the Drug Office website on 18 Nov 2021.
Ends/Tuesday, November 23, 2021
Issued at HKT 15:30
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