This recall was issued due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. 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.

What do you need to do?

• Do not stop taking your medication without speaking with your doctor.
• Please call your doctor to determine if an alternate treatment would be appropriate for you. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption.

For more information or to report any adverse events or quality problems experienced with the use of this product may be made directly to Pfizer, or you can report to the FDA's MedWatch Program.

Manufacturer Information

Pfizer Medical Information (For medical questions):

• 1-800-438-1985, option 3 (Mon-Fri 9am-5pm ET)
• Email: http://www.pfizermedinfo.com/

Pfizer Drug Safety (To report adverse events):

• 1-800-438-1985, option 1 (24 hours a day, 7 days a week)

To report an adverse event to the FDA Med Watch Program

 

• Online: http://www.fda.gov/MedWatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

 

Affected Products and NDC Numbers:

 

Drug	NDC
Chantix 0.5mg	00069-0468-56
Chantix 1mg	00069-0469-56
	00069-0469-03
Chantix Starter Pack	00069-0471-03