FDA is alerting patients and health care professionals that Pfizer is expanding its voluntary recall to include all lots of varenicline (Chantix) 0.5 mg and 1 mg tablets. Pfizer is recalling these lots due to the presence of unacceptable N-nitroso-varenicline levels.
To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.
The agency has temporarily exercised regulatory flexibility and discretion with respect to Apotex's distribution of Health Canada-approved Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit in order to help maintain adequate varenicline supply in the U.S. for the near term.
FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.
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