Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sanofi UK is recalling the following batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin. The affected products are:
- Sabril 500 mg film-coated tablets (batch number: 2989A, 2988D, 2006B)
- Sabril 500 mg granules for oral solution (batch number: 1994A, 2028B)
All patients should be advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride.
Although Sanofi UK has confirmed the presence of tiapride by carrying out analytical testing of impacted batches, the trace amounts of tiapride observed in the source material are significantly lower than permitted daily exposure to tiapride in adults. However, there is a potential risk to children who may have or are taking the impacted batches of Sabril tablets or Sabril granules. This is a theoretical risk as the calculation is based on the amount of tiapride detected in the source material. A precautionary recall is undertaken in view of the potential for serious adverse events in children.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-aventis-pharma-limited-t-slash-a-sanofi-sabril-500-mg-film-coated-tablets-and-sabril-500-mg-granules-for-oral-solution-el-23-a-slash-25
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. As confirmed with Sanofi, the batches recalled in the United Kingdom (batch number: 2989A, 2988D, 2006B) have not been imported into Hong Kong.
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.
Sabril 500 mg granules for oral solution is not a registered pharmaceutical product in Hong Kong.
Ends/Friday, Jul 14, 2023
Issued at HKT 15:00
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