Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets),
Summary
The FDA issued a Class II for Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), by Pfizer Inc.. Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit.
Details
Source
Drug Recall
External ID
D-0700-2021
Action Date
2021-08-11
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
Quantity Affected: 350,985 cartons
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-09
Company
New York, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer Inc. have FDA actions?
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0700-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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