Pfizer Expands Carcinogen-Related Recall of Chantix to All Lots

Pfizer expands voluntary nationwide recall to include all lots of chantix (varenicline) tablets due to the presence of nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit, according to a statement issued today.

• “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” Pfizer said in the statement, citing communications from the FDA
  • “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline,” Pfizer said
• NOTE:
  • July 19, Pfizer issued nationwide voluntary recall ...