Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling specific batches of products 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:
Bristol Laboratories Limited
- Irbesartan 75 mg Film Coated Tablets (batch number: POM0007, POM0008, POM0009, POM0010)
- Irbesartan 150 mg Film Coated Tablets (batch number: PON0005, PON0006, PON0007, PON0008, PON0009)
- Irbesartan 300 mg Film Coated Tablets (batch number: POO0005)
Brown and Burk UK Limited
- Irbesartan 75mg Film Coated Tablets (batch number: IAAG017, IAAG018, IAAG019, IAAG022, IAAG023)
- Irbesartan 150mg Film Coated Tablets (batch number: IABG033, IABG034, IABG035, IABG037, IABG038, IABG039, IABG051)
- Irbesartan 300mg Film Coated Tablets (batch number: IACG027, IACG028, IACG032, IACG035, IACG036, IACG037)
- Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets (batch number: IZAG020)
- Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets (batch number: IZCG010)
- Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets (batch number: IZBG008)
Teva UK Limited
- Losartan potassium 50mg Film Coated Tablets (batch number: 108885)
- Losartan potassium 100mg Film Coated Tablets (batch number: 106077)
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14
In Hong Kong, Losartan-Teva Tab 50mg (HK-58863) and Losartan-Teva Film-Coated Tablets 100mg (HK-63284) are pharmaceutical products registered by Teva Pharmaceutical Hong Kong (Teva), and are prescription-only medicines. As confirmed with Teva, the affected lots have not been imported into Hong Kong.
The other products recalled in the United Kingdom are not registered pharmaceutical products in Hong Kong.
Ends/Friday, Jun 18, 2021
Issued at HKT 16:00
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