D-0809-2021 Class II Ongoing
FDA drug recall D-0809-2021 was initiated by Pfizer Inc. on August 13, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- August 13, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Distribution Pattern
Nationwide
Code Information
Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023