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| The United Kingdom: Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that specific batches of the following irbesartan-containing products are recalled by the Marketing Authorisation Holders and parallel distributor companies as a precautionary measure due to contamination with an impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential. These batches are being recalled as the level of contamination is above the acceptable limit. The affected products are:
Aventis Pharma Limited T/A Sanofi
- Aprovel 75mg Film-Coated Tablets (batch number: 9A111, 9A118)
- Aprovel 150mg Film-Coated Tablets (batch number: 0R258, 0R855, 8R827, 9R217, 9R2N7, 9R40E)
- Aprovel 300mg Film-Coated Tablets (batch number: 0R262, 0R263, 8R830, 9R27A, 9R2N9)
- Co-Aprovel 150mg/12.5mg Film-Coated Tablets (batch number: 0R824)
- Co-Aprovel 300mg/12.5mg Film-Coated Tablets (batch number: 0R16E, 0R2EL, 8R962)
Doncaster Pharmaceuticals Group Ltd
- Aprovel 150mg Film-Coated Tablets (manufacturer’s batch number: FT050)
MPT Pharma Limited
- Aprovel 75mg Film-Coated Tablets (manufacturer’s batch number: 9A111, 9A118)
PCO Manufacturing Ltd
- Co-Aprovel 300mg/12.5mg Film-Coated Tablets (manufacturer’s batch number: FT013)
Gowrie Laxmico Ltd T/A B&S Healthcare
- Aprovel 150mg Film-Coated Tablets (manufacturer’s batch number: FT050)
- Co-Aprovel 150mg/12.5mg Film-Coated Tablets (manufacturer’s batch number: FT037)
Zentiva
- Irbesartan Zentiva 75mg Film-Coated Tablets (batch number: 9A111)
Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing.
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-19
In Hong Kong, Aprovel Tab 150mg (HK-42891), Aprovel Tab 300mg (HK-42892), Coaprovel Tab 150/12.5mg (HK-49777) and Coaprovel Tab 300/12.5mg (HK-49778) are pharmaceutical products registered by Sanofi Hong Kong Limited (Sanofi), and are prescription-only medicines. As confirmed with Sanofi, the affected lots have not been imported into Hong Kong.
Ends/Tuesday, Aug 10, 2021
Issued at HKT 14:00
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