Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.

Recall Number: D-0700-2021

Firm: Pfizer Inc.

Classification: Class II

Status: Ongoing

Report Date: 20210811

Initiation Date: 20210609

Termination Date:

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

Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.