Pfizer Expands Chantix Recall

FDA says Pfizer has expanded its recall of Chantix (varenicline) to 12 lots to the consumer level due to the presence of N-nitroso-varenicline above the company’s acceptable limit for this impurity. The company initially recalled nine lots of the drug 7/2.

An agency update also says FDA is not objecting to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 mg/day but below the interim acceptable intake limit of 185 mg/day until the impurity can be eliminated or reduced to acceptable levels.

The notice says Apotex distributes varenicline in Canada under the name Apo-Varenicline. Under this temporary flexibility and discretion, the company can distribute Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit to help maintain adequate varenicline supply in the U.S. for the near term, the notice says.