藥 物 回 收
|
| |
| The United Kingdom: Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, irbesartan-containing products (English only) |
| |
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
- Co-Aprovel 150mg/12.5mg Film-Coated Tablets (batch number: 9R1PC)
- Co-Aprovel 300mg/12.5mg Film-Coated Tablets (batch number: 9R1P9)
Chemilines Ltd
- Aprovel 150mg Tablets (batch number: FT022)
- Aprovel 300mg Tablets (batch number: FT020)
- Co-Aprovel 150mg/12.5mg Tablets (batch number: FT020)
- Co-Aprovel 300mg/12.5mg Tablets (batch number: FT037)
Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)
- Co-Aprovel 150mg/12.5mg Tablets (batch number: FT020)
Lexon (UK) Ltd
- Aprovel 300mg Tablets (batch number: FT027)
BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)
- Aprovel 150mg Tablets (batch number: FT022, FT040, FT052)
- Aprovel 300mg Tablets (batch number: FT027)
- Co-Aprovel 150mg/12.5mg Tablets (batch number: 9R1PC)
Gowrie Laxmico Ltd T/A B&S Healthcare
- Aprovel 150mg Tablets (batch number: FT022, FT049, FT050)
- Co-Aprovel 150mg/12.5mg Tablets (batch number: FT012, FT020, FT037)
- Co-Aprovel 300mg/25mg Tablets (batch number: FT029)
Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)
- Aprovel 150mg Tablets (batch number: ET065, ET049, ET050, FT022, FT084, ET039)
- Aprovel 300mg Tablets (batch number: FT020)
OPD Laboratories Ltd
- Aprovel 150mg Tablets (batch number: FT051, FT052)
- Co-Aprovel 150mg/12.5mg Tablets (batch number: FT020)
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
In Hong Kong, Aprovel Tab 150mg (HK-42891), Aprovel Tab 300mg (HK-42892), Coaprovel Tab 150/12.5mg (HK-49777), Coaprovel Tab 300/12.5mg (HK-49778) and Coaprovel Tab 300/25mg (HK-55982) are pharmaceutical products registered by Sanofi Hong Kong Limited (Sanofi). All products are prescription-only medicines. As confirmed with Sanofi, the above batches recalled in the United Kingdom have 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 2 Nov 2021.
Ends/Wednesday, Dec 1, 2021
Issued at HKT 15:00
|
| |
|
