Direct Healthcare Professional Communication (DHPC) on CHAMPIX: batches to be recalled due to presence of N-nitroso-varenicline above the accepted intake limit
2021.09.30
Active substance: varenicline
The company Pfizer Pharma GmbH informs that all Champix (varenicline) batches that were found to contain N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled. Based on the available data, there is no immediate risk to patients. For patients who are already on the medicinal product, it may not be possible to complete treatment due to supply shortages. Healthcare professionals may consider switching treatment to an alternative.
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