Medicine recalls
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| Singapore: Recall of six batches of Aprovel Film-Coated Tablet 150mg, Coaprovel Film-Coated Tablet 150／12.5mg and Coaprovel Film-Coated Tablet 300／12.5mg |
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Health Sciences Authority (HSA) announces that Sanofi-Aventis Singapore Pte. Ltd is recalling the following irbesartan-containing products to the retail level. The affected products are:
- Aprovel Film-Coated Tablet 150mg (batch number: AA365)
- Coaprovel Film-Coated Tablet 150/12.5mg (batch number: AA557)
- Coaprovel Film-Coated Tablet 300/12.5mg (batch number: AA510, AA549, AA552, AA527)
During recent testing, an impurity, [5-(4’-(azidomethyl)-[1,1’-biphenyl]-2-yl)-1H-tetrazole], was found to be above the acceptable level in several batches of Aprovel Film-Coated Tablet 150mg, Coaprovel Film-Coated Tablet 150/12.5mg, and Coaprovel Film-Coated Tablet 300/12.5mg. As a precautionary measure, the affected batches are recalled.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-six-batches-of-aprovel-film-coated-tablet-150mg-coaprovel-film-coated-tablet-150-12.5mg-and-coaprovel-film-coated-tablet-300-12.5mg
In Hong Kong, Aprovel Tab 150mg (HK-42891), 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.
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.
As confirmed with Sanofi, Coaprovel Film-Coated Tablet 300/12.5mg (batch number: AA552, AA527) have not been imported into Hong Kong.
Related news was previously issued by Macau Health Bureau and Taiwan Food and Drug Administration, and was posted on the Drug Office website on 25 Oct 2021 and 1 Nov 2021 respectively.
Ends/Tuesday, Nov 2, 2021
Issued at HKT 15:00
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