27 Apr Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo
| Company name &
Address |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South
Africa |
41/34/0573- 41/34/0572 |
18069 |
31Aug-2021 |
Starter Pack 0.5mg/1mg Film Coated Tablet 1×11+3×14 |
12 Apr-2019 |
Class III Type B |
19 August 2021 |
Reason for recall
Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.
Advice to HCPs/Distributors/Public:
The company requested the immediate return of all the affected batch of Champix to the supplying distributor for full credit without delay. As a precautionary measure, distribution remains on hold of all Distribution Points under Pfizer control
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.