16-Aug-21 [O] (Mon) 20:11

 

 

[Nationwide U.S. & P.R.][Pharma][CHANTIX® Varenicline – UD# 3]

 

Snapshot

 

Pfizer Expands Recall to Include Four Additional Lots CHANTIX® (Varenicline) Tablets (excessive nitrosamine impurity – N-nitroso-varenicline)

 

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

***

To date, Pfizer has not received any reports of adverse events that have been related to this recall.

 

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below with the four additional lots. Photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.

 

Chantix (varenicline)

 

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

 

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

 

 

 

 

 

End of Snapshot – Full Text Follows

 

 

 

 

Pfizer Expands Recall to Include Four Additional Lots CHANTIX® (Varenicline) Tablets (excessive nitrosamine impurity – N-nitroso-varenicline)

[FDA][08/16/2021 19:51]

 

Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso Varenicline Content

 

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

 

Read Announcement  View Product Photos  Print

 

COMPANY ANNOUNCEMENT

 

Summary

 

Company Announcement Date:

August 16, 2021

 

FDA Publish Date:

August 16, 2021

 

Product Type:

Drugs

 

Reason for Announcement:

N-Nitroso Varenicline content above acceptable daily intake level

 

Company Name:

Pfizer

 

Brand Name:

CHANTIX

 

Product Description:

Smoking cessation treatment

 

Company Announcement

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

 

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. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. i

 

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. ii Smoking is also associated with many other cancers. iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

 

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below with the four additional lots. Photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.

 

Product

NDC

Lot Number

Expiration Date

Presentation

Configuration/Count

Chantix
(varenicline) Tablets, 0.5 mg

0069-0468-56

00019213

2022 JAN

Bottles

56 tablets/bottle

Chantix
(varenicline) Tablets, 0.5 mg

0069-0468-56

EC6994

2023 MAY

Bottles

56 tablets/bottle

Chantix
(varenicline) Tablets, 1 mg

0069-0469-56

EA6080

2023 MAR

Bottles

56 tablets/bottle

Chantix
(varenicline) Tablets, 1 mg

0069-0469-56

EC9843

2023 MAR

Bottles

56 tablets/bottle

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00018522

2021 AUG

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00018523

2021 AUG

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00018739

2021 AUG

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00018740

2021 AUG

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00020231

2021 SEP

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00020232

2021 NOV

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00020357

2021 DEC

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00020358

2022 JAN

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

00020716

2022 JAN

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

ET1600

01/2023

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

ET1607

01/2023

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

Chantix (varenicline) Tablets, 0.5/1 mg

0069-0471-03

ET1609

01/2023

Cartons containing 2 blister packs

Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets


Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

 

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

 

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Stericycle at 888-276-6166 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

 

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Stericycle Inc. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Stericycle Inc. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8:00 am – 6:00 pm ET).

 

As communicated by FDA, there is no immediate risk to patients taking Chantix. iv Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

 

Contact Center

Contact Information

Area of Support

Pfizer Medical
Information

800-438-1985, option 3
(Mon.-Fri. 9 am-5 pm ET) www.pfizermedinfo.comExternal Link Disclaimer

For medical
questions regarding the product

Pfizer Drug Safety

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

To report adverse events and product complaints


Adverse events or product complaints experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

 

References:

I https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications

ii U.S. Centers for Disease Control and Prevention. What Are the Risk Factors for Lung Cancer? https://www.cdc.gov/cancer/lung/basic_info/risk_factors.htm Updated September 2020. Accessed June 2021.

Iii U.S. Department of Health and Human Services. Smoking and Cancer (Fact Sheet). Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.

Iv https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse

 

Company Contact Information

 

Consumers:

Pfizer Medical Information

800-438-1985, option 3

 

Media:

Eamonn Nolan

212-733-4626

Eamonn.Nolan@pfizer.com

 

Product Photos

Chantix (varenicline) Tablets, 0.5 mg

Chantix (varenicline) Tablets, 1.0 mg

Chantix (varenicline) Tablets, 0.5/1 mg, Starting Month Box

 

Content current as of:

08/16/2021

Regulated Product(s)

Drugs

 

####

 

Related FoodTrack Bulletin(s):

 

Recall 20-Jul-21 [E] (Tue) 09:15 [Nationwide U.S. & P.R.][Pharma][CHANTIX® Varenicline – UD# 2]:

Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

 

Recall 3-Jul-21 [D] (Sat) 20:22 [Canada][Pharma][Varenicline – UD# 1]:

Pfizer Canada ULC Recalls 5 Impacted Lots of Smoking-Cessation Rx Medication CHAMPIX (Varenicline) (excessive Nitrosamine Impurity – N-nitrosovarenicline)

 

Recall 3-Jul-21 [C] (Sat) 17:07 [US – Warehouse Level][Pharma]:

FDA Alerts Health Care Professionals and Patients to Pfizer’s Voluntary Recall of Nine Lots of the Smoking Cessation Drug, Varenicline (Chantix) to the Warehouse Level (excessive nitrosamine impurity – N-nitroso-varenicline)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INFO@FoodTrack.Net ª www.FoodTrack.Net ª Toll Free: (800) 397-7202

REDISTRIBUTION: UNAUTHORIZED REDISTRIBUTION PROHIBITED. The FoodTrack service, communications, content, software and information (collectively, the "FoodTrack Materials") are protected by copyright and trade secret laws.  The FoodTrack Materials are distributed to Client Recipients for Client's private use, and any redistribution or retransmission of FoodTrack Materials, including by framing or similar means, is expressly prohibited.  Client agrees and covenants that they will not copy, distribute, transmit or otherwise provide any FoodTrack Materials to any other party, nor assist or permit any other party in doing so.  Should Client breach this covenant, FoodTrack may immediately terminate this Agreement without notice to Client, with no refund to Client.

 

DISCLAIMER:  Client agrees that FoodTrack Inc., nor any of its employees, distributors, affiliates, agents or licensors warrant the accuracy,  completeness, currentness, merchantability or fitness for a particular purpose of the  information contained herein. In no event will FoodTrack, Inc. or any of its employees, distributors, affiliates, agents or licensors be liable for any loss, including consequential, special or similar damages, resulting directly or indirectly from subscriber’s use of the services, information or the equipment, or from any decision made or action taken by subscriber or any third party in reliance upon information contained herein.  In no event shall the liability of FoodTrack, Inc., its employees, distributors, affiliates, agents and licensors arising out of any claim related to this agreement exceed the aggregate amount paid by client, to Foodtrack, Inc. for services/equipment provided in the 12 months immediately preceding the event giving rise to such claim. “Client” or “Recipient” shall include samplers receiving complimentary copies of this alert.