Why it was recalled
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Product description
Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.
Lot numbers, UPCs & expiration codes
Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 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-0809-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 13, 2021
- FDA report date
- Sep 29, 2021
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0809-2021, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 88497
- Address
- 235 East 42nd Street
- Code information
- Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023
- Postal code
- 10017-5703
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0809-2021
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Reason for recall
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 13, 2021
- Initial firm notification
- Press Release
- Center classification date
- Sep 17, 2021