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| The United Kingdom: Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, irbesartan-containing products: Update (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that one additional batch of Aprovel 150mg Tablets (batch number: ET042) is recalled by BR Lewis Pharmaceuticals Ltd as a precautionary measure due to contamination with an impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential. The batch is being recalled as the level of contamination is above the acceptable limit.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34#history
In Hong Kong, Aprovel Tab 150mg (HK-42891) is a pharmaceutical product registered by Sanofi Hong Kong Limited (Sanofi). The product is a prescription-only medicine. As confirmed with Sanofi, the above batch recalled in the United Kingdom has not been imported into Hong Kong.
On 21 Oct 2021, the Department of Health endorsed Sanofi to recall five batches of the following four products from the market as a precautionary measure due to the presence of an impurity in the products:
- Aprovel Tab 150mg (HK-42891) (batch number: AA365)
- Aprovel Tab 300mg (HK-42892) (batch number: AA691)
- Coaprovel Tab 150/12.5mg (HK-49777) (batch number: AA557)
- Coaprovel Tab 300/12.5mg (HK-49778) (batch number: AA510, AA549)
A press statement was issued on the same date.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 10 Aug 2021, with the latest update posted on 1 Dec 2021.
Ends/Thursday, Dec 2, 2021
Issued at HKT 15:00
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