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| Singapore: Recall of all batches of Champix Tablet Starter Pack and Champix Tablet 1mg (English only) |
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The Health Sciences Authority (HSA) announces that Pfizer Private Limited is recalling the following Champix (varenicline) products to the retail level. The affected products are:
- Champix Tablet Starter Pack (batch number: 24817, 26737)
- Champix Tablet 1mg (batch number: 25602, 26557)
An impurity, N-nitrosovarenicline, was found to be above the acceptable level in batches of Champix Tablet Starter Pack and Champix Tablet 1mg. 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-all-batches-of-champix-tablet-starter-pack-and-champix-tablet-1mg
In Hong Kong, Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are registered pharmaceutical products containing varenicline. Both products are registered by Pfizer Corporation Hong Kong Limited (Pfizer), and are prescription-only medicines. As confirmed with Pfizer, all the in-date batches of Champix in Hong Kong have been recalled from market.
On 27 Sep 2021, the Department of Health (DH) endorsed Pfizer to recall a total of 5 batches of the following 2 products from the market as a precautionary measure due to the presence of an impurity in the products:
- Champix Tab 0.5mg & 1mg (HK-55462; batch number: 00023530, 00026657)
- Champix Tab 1mg (HK-55437; batch number: 00023023, 00025603, 00026556)
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 16 Jun 2021, with the latest update posted on 15 Oct 2021.
Ends/Wednesday, Nov 17, 2021
Issued at HKT 14:00
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