Pfizer Chantix (Varenicline) Tablet Recall [US]


Pfizer Chantix Tablet Recall [US]

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US FlagUS/Silver Spring: Pfizer, a Manhattan, New York establishment, recalls certain batch/lots of Chantix Tablets due to the presence of N-nitroso-varenicline contamination and consequential risks of increased carcinogenicity (Cancer), severe illness and/or possible life-changing complications, all serious health and safety hazards/situations requiring immediate medical intervention to minimize suffering and prevent life-changing injury.

FDA: http://ht.ly/sDqw30rRBS6

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Chantix (Varenicline) Tablets are subject to this recall:

  • Chantix (varenicline) Tablets, 0.5 mg, sold with an NDC designation of 0069-0468-56, a batch/lot of 00019213 and an expiration date of 2022 JAN
  • Chantix (varenicline) Tablets, 0.5 mg, sold with an NDC designation of 0069-0468-56, a batch/lot of EC6994 and an expiration date of 2023 MAY
  • Chantix (varenicline) Tablets, 1 mg, sold with an NDC designation of 0069-0469-56, a batch/lot of EA6080 and an expiration date of 2023 MAR
  • Chantix (varenicline) Tablets, 1 mg, sold with an NDC designation of 0069-0469-56, a batch/lot of EC9843 and an expiration date of 2023 MAR
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00018522 and an expiration date of 2021 AUG
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00018523 and an expiration date of 2021 AUG
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00018739 and an expiration date of 2021 AUG
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00018740 and an expiration date of 2021 AUG
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00020231 and an expiration date of 2021 SEP
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00020232 and an expiration date of 2021 NOV
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00020357 and an expiration date of 2021 DEC
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00020358 and an expiration date of 2022 JAN
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of 00020716 and an expiration date of 2022 JAN
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of ET1600 and an expiration date of 01/2023
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of ET1607 and an expiration date of 01/2023
  • Chantix (varenicline) Tablets, 0.5/1 mg, sold with an NDC designation of 0069-0471-03, a batch/lot of ET1609 and an expiration date of 01/2023

Please consult the photograph above for details of the drug’s packaging, design and retail/wholesale presentation.

==> No barcodes, DINs, UPCs, item numbers, best-before date codes, manufacturing date codes, production dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to the FDA, Pfizer has recalled certain batch/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. As a result of this recall, you should neither serve nor consume the recalled Chantix medications identified above.

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. Pfizer reports the health benefits of stopping smoking outweigh the theoretical potential Cancer risk from the nitrosamine impurity in varenicline.

Pharmacies should cease dispensing these identified medications. 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.

==> Never stop taking your prescription medications, including Chantix (varenicline) Tablets, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

==> You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this or other drug product.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat N-Nitrosodimethylamine (“NDMA”) contamination.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Chantix (varenicline) Tablets, please search for “Chantix” using the Search Box at the top of this page.

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Pfizer products being recalled should contact Stericycle Inc. toll-free at 1-888-276-6166 during normal business hours Eastern Standard Time, Monday to Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer Medical Information toll-free at 1-800-438-1985, option 3, from 9:00 AM to 5:00 PM Eastern Standard Time (“EST”) or visit the company’s Web site at http://www.pfizermedinfo.com.

For medical questions regarding this product, please contact Pfizer Drug Safety toll-free at 1-800-438-1985, option 1, 24 hours-a-day, 7 days-a-week)

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Chantix Tablets, please search for “Chantix” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected N-Nitrosodimethylamine contamination, please search for “NDMA” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Pfizer, please search for “Pfizer” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Carcinogenic contamination, please search for “Cancer” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14814-2021
Want to read more about this recall?
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General information:
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