Medicine recalls
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| Singapore: Recall of one batch of Dotarem Injection 27.932g／100ml |
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The Health Sciences Authority (HSA) announces that Transmedic Pte Ltd is recalling one batch of Dotarem Injection 27.932g/100ml (gadoteric acid) (batch number: 20GD075B) to the retail level.
During sample inspection, some vials had evidence of external leaks of the solution (dry product on the external surface of the vials). This is due to the defect of the neck of the glass vials supplied.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-one-batch-of-dotarem-injection-27.932g-100ml
In Hong Kong, Dotarem Inj 377mg/ml (vial) (HK-41578) is a pharmaceutical product registered by Guerbet Asia Pacific Ltd (Guerbet). 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. As confirmed with Guerbet, the above affected batch in Singapore is of 10ml vial and has 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 (including the above affected batch) 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 Health Canada, and was posted on the Drug Office website on 18 Nov 2021 and 23 Nov 2021 respectively.
Ends/Saturday, November 27, 2021
Issued at HKT 12:00
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