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Pfizer

Updated: September 16, 2021 9:02 PM
Company name: Pfizer
Brand name: CHANTIX
Product recalled: Varenicline tablets
Reason of the recall: N-nitroso-varenicline above acceptable daily intake level
FDA Recall date: September 16, 2021
Recall details: Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level... See More due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure. 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. Check the link below for the full list of the recalled products.

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.

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.

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease. 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 healthcare provider about alternative treatment options.

To date, Pfizer has not received reports of adverse events assessed to be related to this recall. The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets are indicated in Appendix A. Photos of the products can be found in Appendix B.

The products were distributed nationwide to Wholesalers and Distributors in the United States, US Virgin Islands, and Puerto Rico from May 2019 to September 2021. 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 Chantix tablets, 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.

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. Additionally, if you are aware of any patients to whom you dispensed the products and who still may have the product in their possession, please ask them to return the product.

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 to determine if alternative treatments are available.

Check the full recall details on fda.gov

Source: FDA
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93


Friend of mine (age 60) was vaccinated by Pfizer, both doses. Became infected with virus from co-worker. Test by doctor did show positive results. Had no symptoms. Had previous lung conditions prior to infection, but overall good health besides. See Less
316


My 38 year old husband felt unusually tired on a Friday and went to bed early. Saturday and Sunday he worked but said he felt “off” and took allergy medication as he had no fever. Sunday afternoon (8.22.21), he took a long nap and awoke to what... See More seemed to be the flu. High fever (above 101°), chills, body aches, headache, nausea, sore throat, deep chesty cough and congestion. He was immediately tested for Covid and it was positive. I am getting tested tomorrow (day 5 after exposure) but we were both fully vaccinated (Pfizer) by March 26th. | Symptoms: Nausea, Fever, Other, Headache, Chills, Body Ache See Less
71


I had the Pfizer vaccine. Symptoms from that were sore arm for two days and tiredness for about 5 days. 2nd jab in April just a sore arm for a day.
Fast forward to 22nd of August, cough and sore throat developed, Monday 23rd no different in... See More symptoms, Tuesday getting progressively worse with body aches and headache. Sleep is difficult. Thursday (today) one paracetamol every two hours helped with sleeping rather than two every four hours. Slept much better, feeling a little better. Headache milder, sneezing lots and runny nose. | Symptoms: Headache, Fatigue, Body Ache, Soreness See Less
371


Vaccinated with two doses of phizer vaccine mid February. Caught covid 7/30/21 with congestion and no taste or smell. Symptoms lasted for 6 days. | Symptoms: Other See Less
7.0K


Both my friend and brother contracted Covid-19 after being fully vaccinated with both doses (one had Pfizer, one Moderna). Both experienced moderate symptoms for about a week. See Less
1.8K


I was given the second dose of the vaccine and everything was very fast in the Benalcazar, there was practically no one and a side effect I only had a little pain in my arm for a day and a half | Symptoms: Soreness See Less
8


Booster shot Pfizer received today, no adverse symptoms. Date of shot 23 August 2021, condition mild injection site soreness gone within 24 hours. No other symptoms. | Symptoms: Soreness See Less
3.7K


Got the first dose of Pfizer. 5 hours after, intense migraine started that lasted for two days. Body ache, fever, nausea, and chills started on the 2nd day. Sore arm lasted four days. | Symptoms: Nausea, Fever, Headache, Chills, Body Ache, Soreness See Less
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