Pfizer Inc.: Drug Recall
Recall #D-0808-2021 · 08/13/2021
Class II: Risk
Recall Details
- Recall Number
- D-0808-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pfizer Inc.
- Status
- Ongoing
- Date Initiated
- 08/13/2021
- Location
- New York, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Product Description
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
Distribution Pattern
Nationwide
Other Recalls by Pfizer Inc.
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.