Pfizer issues a voluntary recall for 12 lots of Chantix

Chantix3

Photo courtesy of FDA.gov

Pfizer has voluntary recalled several lots of its anti-smoking drug, Chantix.

They contain presence of a nitrosamine chemical, N-nitroso-varenicline, that may cause cancer. Pfizer says the possible carcinogen was detected in 12 lots at levels above the company’s established acceptable daily intake.

The company says long-term ingestion of the chemical may be associated with potential increased cancer risk. However, Pfizer says the health benefits of stopping smoking outweigh the potential risk.

The FDA says people should continue taking the medicine until their pharmacist provides a replacement, or their doctor prescribes a different medication.

The NDC, Lot Number, Expiration Date, Packaging and Configuration details for Chantix Tables is indicated below:

  • 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
    • 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 (2023 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
    • ET1607
    • 01/2023 (2023 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
    • ET1609
    • 01/2023 (2023 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

Wholesalers and distributors with an existing inventory of the lots should stop use and distribution and quarantine the product immediately.

Patients who are taking Chantix 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 1-888-276-6166 (Mon.-Fri. 8 a.m. – 5 p.m. ET) for instructions on how to return their product and obtain reimbursement for their cost.

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