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Direct Healthcare Professional Communication (DHPC) on CHAMPIX: Batch recall due to contamination with N-nitroso-varenicline above Pfizer's acceptable daily dose

Active substance: Varenicline

The company Pfizer would like to inform that several batches of the drug CHAMPIX are being recalled, in which the impurity N-nitroso-varenicline above the daily dose accepted by Pfizer has been detected, as a precaution, Pfizer is pausing distribution until further testing has been conducted. Based on available data, there is no immediate risk to patients taking the medication. While testing is ongoing, as a precaution, healthcare professionals should not start patients on CHAMPIX.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 71KB, File is accessible