Pfizer Expands Chantix Recall to Include All Lots

Pfizer is expanding its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential 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,” an agency notice says.

The agency also says it has temporarily exercised regulatory flexibility and discretion to permit 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 supply of the smoking cessation product.