D-0699-2021 Class II Ongoing
FDA drug recall D-0699-2021 was initiated by Pfizer Inc. on June 9, 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. Affected quantity: 59,232 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 11, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,232 bottles
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 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023