Recall of all batches of Champix Tablet Starter Pack and Champix Tablet 1mg

Retail-level recall of all batches of Champix Tablet Starter Pack and Champix Tablet 1mg, containing varenicline, due to impurity above acceptable level.

Date of recall:

16 November 2021

Product:

Champix Tablet Starter Pack and Champix Tablet 1mg

Active Ingredient:

Varenicline

Product Category:

Therapeutic product

Batch No.:

Please refer to Annex for the affected batches

Class of Recall:

2

Level of Recall:

Retail

Local Company:

Pfizer Private Limited

Description of Issue:

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.

Recall Instructions:

Hospitals, clinics, pharmacies:

Stop supplying the affected batches and return the remaining stocks to the company.

Patients are advised to continue taking their Champix medication as prescribed by their doctors as the medicine is important in aiding with their smoking cessation programme. Patients are encouraged to speak to their doctors if they have any concerns relating to the use of Champix tablets.

 

Annex

Product Name

Registration Number

Batch Number

Expiry Date

Champix Tablet 1mg

SIN13323P

25602

31 Mar 2022

Champix Tablet 1mg

SIN13323P

26557

30 Sep 2022

Champix Tablet Starter Pack

SIN13322P

24817

28 Feb 2022

Champix Tablet Starter Pack

SIN13322P

26737

30 Sep 2022

 

Note:

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy. 

When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.

Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.

 

Class of recall

A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.

  • Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
  • Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.

 

Level of recall

The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.

  1. Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
  2. Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
  3. Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.

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