Why it was recalled
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Product description
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Lot numbers, UPCs & expiration codes
Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0700-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 9, 2021
- FDA report date
- Aug 11, 2021
- Quantity
- 350,985 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0700-2021, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 88077
- Address
- 235 East 42nd Street
- Code information
- Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
- Postal code
- 10017-5703
- Report date
- Aug 11, 2021
- Product type
- Drugs
- Recall number
- D-0700-2021
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 350,985 cartons
- Reason for recall
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2021