Medicine recalls
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| Singapore: Recall of Sabril Tablet 500mg |
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Health Sciences Authority (HSA) announces that Sanofi-Aventis Singapore Pte. Ltd is recalling one batch of Sabril Tablet 500mg (vigabatrin) (batch number: 2991A) to the retail level. Trace amount of tiapride were detected in the affected batch of Sabril Tablet 500mg. As a precautionary measure, the company is voluntarily recalling the affected batch of Sabril Tablet 500mg.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-sabril-500mg-tablet
In Hong Kong, Sabril Tab 500mg (HK-35365) is a pharmaceutical product registered by Sanofi Hong Kong Limited (Sanofi). The product is a prescription-only medicine.
On 13 Jul 2023, the Department of Health (DH) endorsed Sanofi to recall one batch (batch number: 2991A) of Sabril Tab 500mg (HK-35365) from the market due to potential quality issue. The DH received notification from Sanofi that the overseas manufacturer of the product reported that trace amount of an impurity identified as tiapride was detected in the product. The most probable cause was due to carryover of tiapride on the same equipment during production of active ingredient vigabatrin. The level of tiapride detected was below the permitted daily exposure. As a precautionary measure, Sanofi is voluntarily recalling the affected product from the market. A recall statement was posted on the Drug Office website on the same date.
Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency and Macao Pharmaceutical Administration Bureau, and was posted on the Drug Office website on 14 Jul 2023.
Ends/Friday, Jul 21, 2023
Issued at HKT 16:00
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