Pfizer Expands Voluntary Recall Nationwide To Include All Lots Of Chantix Tablets | WGN 720 radio

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The FDA released what follows:

Pfizer is voluntarily recalling all batches of Chantix 0.5 mg and 1 mg tablets from the patient (consumer / user) due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the limit FDA interim acceptable intake. As alternative suppliers have been approved in the United States, Pfizer is taking this precautionary measure.

Long-term ingestion of N-nitroso-varenicline may be associated with a potential theoretical increased risk of cancer in humans, but there is no immediate risk for patients taking this drug. The health benefits of quitting 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 can increase the risk of cancer if people are exposed to them at levels 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 develop lung cancer than people who do not smoke.ii

Smoking is also associated with many other cancers, as well as cardiovascular and lung disease.iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a strong clinical program. Pfizer believes that the benefit / risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult their health care provider about alternative treatment options. To date, Pfizer has not received any reports of adverse events assessed as being related to this recall.

The NDC, lot number, expiration date and configuration details of Chantix tablets are shown in Appendix A. Photos of the products can be found in Appendix B. The products have been distributed nationwide to wholesalers and distributors in the United States, the United States Virgin Islands and Puerto Rico from May 2019 to September 2021.

Pfizer places the highest importance on patient safety and product quality at every stage of the manufacturing process and supply chain. Pfizer has notified its direct recipients by letter to arrange for the return of any recalled product.

Wholesalers and distributors with existing inventory of Chantix tablets should cease use and distribution and quarantine the product immediately.

If you have continued to distribute the recalled product, please notify any additional accounts or locations that may have received the recalled product from you. Please sub-recall on these accounts and communicate this recall information immediately. Please ask them to immediately cease distribution of the product and promptly contact Stericycle at 888-276-6166 (Monday to Friday 8:00 a.m. to 5:00 p.m. ET) to obtain a Commercial Response Form (BRF) to initiate the return process. .

If you have received a free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your inventory immediately. If you have a product in stock, please follow the instructions above to return the product to Stericycle Inc. In addition, if you know of any patients to whom you have distributed the products who may still have the product in their possession, please ask. to return the product to you, then follow the instructions above to return the product to Stericycle Inc. If you have any questions about the Pfizer PAP or Pfizer IPAP product, please contact 833-203-2776 (Monday through Friday at 8:00 a.m. ). a.m. – 6 p.m. ET).

As communicated by the FDA, there is no immediate risk to patients taking Chantix.iv Patients taking this product should consult their health care provider to determine if other treatments are available. Patients with Chantix tablets should contact Stericycle Inc. at 888-276-6166 (Monday to Friday 8:00 a.m. to 5:00 p.m. ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare professionals with questions regarding this recall may contact Pfizer using the information below.

Call center Contact details Support zone
Pfizer medical information 800-438-1985, option 3 (Mon-Fri 9 am-5pm ET)
www.pfizermedinfo.comDisclaimer regarding external links
For medical questions regarding the product
Pfizer Medication Safety 800-438-1985, option 1 (24 hours a day; 7 days a week) To report adverse events and product complaints

Adverse reactions or quality issues encountered while using this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program, online, by mail, or by fax.

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

This recall is being carried out with the knowledge of the United States Food and Drug Administration.

Appendix A: Details of the recalled product

PRODUCT: Chantix tablets, 0.5 mg NDC: 0069-0468-56
CUT: Bottle of 56 Tablets
EXPIRATION DATE: January 2022 – May 2023
LOT NUMBERS:

00019213 DM9007 EC6994 EN8362
CY6861 DM9008 EN5725 EN8467

PRODUCT: Chantix tablets, 1 mg NDC: 0069-0469-56
CUT: Bottle of 56 Tablets
EXPIRATION DATE: September 2021 – December 2023
LOT NUMBERS:

00018777 00021024 CW1572 DF5280 DY7987 EN5694
00019289 00021073 CW1573 DF5281 EA6080 EN5695
00019593 00021074 CW1574 DF5282 EC9841 EP1717
00019682 CW1565 CW1575 DR5086 EC9842 EP1718
00019846 CW1566 CW1578 DR5092 EC9843 EP1719
00019977 CW1567 CW1579 DR5093 EC9847 EW2012
00020295 CW1568 CW1581 DR5094 EC9848 EW3854
00020448 CW1569 DF5277 DT3885 EE1011 EW3865
00020458 CW1570 DF5278 DW4148 EM1069 EX2102
00020480 CW1571 DF5279 DW4152 EM1070 EX2103

PRODUCT: Chantix tablets, 1 mg NDC: 0069-0469-03
CUT: Carton containing 4 blisters of 14 tablets each
EXPIRATION DATE: September 2021 – June 2023
LOT NUMBERS:

00019431 00021421 00022765 DR2614 DY7060 EE9391
00019542 00021422 00022766 DX4576 DY9367 EF2346
00019543 00021423 00023134 DX5870 DY9473 EM4805
00019544 00022136 00023135 DX5871 DY9475 EM4807
00020814 00022174 00023747 DX5872 DY9476 FR2005
00020815 00022175 00023748 DX5873 DY9505 ET1601
00020907 00022176 DL3896 DX7805 EC5910 ET1605
00020965 00022177 DL7779 DY6078 EC5913 ET1606

PRODUCT: Chantix tablets, 0.5 / 1 mg NDC: 0069-0471-03
CUT: Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
EXPIRATION DATE: August 2021 – January 2023
LOT NUMBERS:

00018522 00020358 00021688 00022851 DM0277 ET1607
00018523 00020716 00021788 00023136 DY4470 ET1609
00018739 00020813 00021789 00023137 EC5911 ET1611
00018740 00021288 00021790 00023190 EC5912
00020231 00021289 00021791 00023448 ED6814
00020232 00021420 00021792 DM0275 ET1600
00020357 00021687 00022819 DM0276 ET1603

The references:

Ihttps://www.fda.gov/drugs/drug-safety-and-available/information-about-nitrosamine-impurities-medidications

ii US 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 US Department of Health and Human Services. Smoking cessation. A report from the Surgeon General. Atlanta, GA: US Department 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, 2020.

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

Previous recall notices: original recall | Extended recall


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