fbpx

FDA Announces Expanded Recall of All 0.5mg and 1mg Chantix Pills

The U.S. Food and Drug Administration (FDA) recently announced an expanded recall of Chantix (varenicline) to include all lots of 0.5mg and 1mg tablets. Pfizer is pulling the smoking cessation drug because of concerning levels of N-nitroso-varenicline, which may be associated with an increased risk of cancer in humans.

Timeline of Expanded Recall for Chantix

On July 2, 2021, the FDA first notified patients and providers about the recall of nine lots of Chantix. At this point, Pfizer recalled a limited number of products due to the presence of the nitrosamine. 

Nitrosamines are commonly found in water and foods, meaning that everyone is exposed to them in some way. However, the risk of cancer may increase if people are exposed at high levels over a long period of time. Still, the FDA noted that there was no immediate risk to patients taking the mediation. In fact, the benefits of quitting smoking outweighed the theoretical and potential risk of cancer.

Pfizer continued selling the believed-to-be safe lots of the smoking cessation drug. Then, on July 19, 2021, the company expanded the recall to 12 lots, based on the same concern as the initial recall. 

Approximately a month later, on August 18, 2021, the manufacturers added four more lots to the list. Then, per the most recent update, Pfizer issued a statement about the final expanded recall, which is inclusive of all lots of of the 0.5mg and 1mg tablets. As they work to reduce or eliminate the impurity in future lots, the FDA said that it would not object to “certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above the acceptable limit intake of 37ng per day but below the interim acceptable intake limit of 185ng per day.”

Connection to Other Recent Recalls

Similarly, the FDA requested the removal of all Zantac from shelves in April 2020. There was concern that the heartburn drug contained unsafe levels of N-nitrosodimethylamine (NDMA), another impurity related to cancer. As a result, multiple lawsuits have been filed against the manufacturers.

Several other drugs, including high blood pressure medications like valsartan and losartan, have been impacted by nitrosamine impurities in recent years. This issue may be caused by changes in manufacturing as well as improved testing methods that allow the components to be identified at very low levels. 

For more information about the halted distribution of Chantix, contact us today.

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.

Drug Law Journal Legal Sponsorship

Drug Law Journal's publishing and research are sponsored by the DDP Injury Law Group in Washington, D.C. Their legal team is focused on protecting the rights of injury victims.
Furthermore, they understand and appreciate the importance of a trusted attorney-client relationship.
The DDP Injury Law Group uses their years of experience with litigation to ensure their clients can fight for the compensation they deserve.

Always seek the advice of a medical professional when making personal health choices.

The Offices of DrugLawJournal.com are located at:

1800 North Orange Avenue, Suite C
Orlando, Florida 32804

DrugLawJournal.com is sponsored by the DDP Injury Law Group, and therefore may be considered attorney advertising. The information contained on DrugLawJournal.com is provided for informational purposes only, and should not be construed as legal or medical advice on any subject matter. No viewers of this site should discontinue taking a prescribed medication on the basis of any information on this site and should always first consult with a doctor concerning any medication. Viewers should understand that if they refrain from taking prescribed medication without appropriate medical advice they can suffer injury or death.

No viewers of content from this site, clients or otherwise, should act or refrain from acting on the basis of any content included in the site without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from an attorney licensed in the viewer’s state. Viewing information from DrugLawJournal.com does not create an attorney-client relationship between you and DDP Injury Law Group or DrugLawJournal.com nor is it intended to do so.The content of DrugLawJournal.com may not reflect current legal developments, verdicts or settlements. Prior results do not predict a similar outcome. For more information, please visit our web site’s disclaimer.

©2024 DrugLawJournal.com | Privacy Policy | Terms & Conditions

Stay Informed

Sign up to receive peroidic updates from our expert team of researchers, highlighting defective drugs, devices, and legal issues related to your health.

Email Catcher
Free Drug and Medical Device Case Review

Free Drug and Medical Device Case Review

Share your story with us and we will reach out to you about your case.

First
Last
Described what happened to you, we will review and reach out to you about your situation.

It is important for those who have suffered injury from dangerous drugs and medical devices to know that they have may have options.

Consumers have the ability to seek legal remedies for their injuries resulting from the negligence of drug and device manufacturers. The first step toward justice and recovery is sharing your story with effective legal counsel. An attorney will help you to better understand the issues and discuss the possibility of compensation for your suffering.

Once you complete the information request above, Drug Law Journal will send the information to a specialist at our legal sponsor’s firm, the DDP Injury Law Group, in Washington, D.C. That specialist will follow-up with you directly to gather further specific information about your case and make an evaluation. If the firm is able to move forward on your case, they will also discuss next steps. Remember – the entire consult and evaluation is free to you. You only need to take the first step to fill out the contact form or call: (800) 597-1870 for immediate assistance.