Drugplain

CHANTIX

varenicline tartrate · KIT · Proficient Rx LP

10 Recalls on Record
Plain English

CHANTIX is a kit containing varenicline tartrate. Manufactured by Proficient Rx LP.

Key Facts

Brand Name
CHANTIX
Generic Name
varenicline tartrate
NDC Code (Product)
63187-618
Manufacturer
Proficient Rx LP
Dosage Form
KIT
Marketing Status
Application #
NDA021928
Marketing Start
05/10/2006

Recall History

10 Recalls on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II08/13/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II08/13/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II06/09/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II08/13/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II06/09/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II08/13/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II06/09/2021

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

OngoingVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is CHANTIX used for?

CHANTIX contains varenicline tartrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is CHANTIX a controlled substance?

CHANTIX is not classified as a controlled substance by the DEA.

What is the generic name for CHANTIX?

The generic name for CHANTIX is varenicline tartrate. There are 9 other brand versions of varenicline tartrate.

What is the NDC code for CHANTIX ?

The NDC (National Drug Code) for CHANTIX is 63187-618, listed by Proficient Rx LP.