Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Ltd is recalling all in-date batches of Champix (varenicline) as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake set by both European Medicines Agency and MHRA. The affected products are:
- Champix 0.5mg film-coated tablets
- Champix 0.5mg + 1mg film coated tablets
- Champix 1mg film-coated tablets
This recall also includes parallel imported/distributed products. The affected product is:
- Champix 1mg Film-Coated Tablets (parallel distributed by Drugsrus Limited)
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-ltd-champix-all-strengths-film-coated-tablets-el-21-a-slash-25
In Hong Kong, Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are registered pharmaceutical products containing varenicline. All 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 18 Sep 2021.
Ends/Friday, Oct 15, 2021
Issued at HKT 16:00
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