Drug recall D-0699-2021
Product
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
Lots and codes
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 59,232 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 9, 2021
Related products
- Chantix – drug information
- NDC 0069-0471 Chantix · · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-0468 Chantix · Varenicline Tartrate .5 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-0469 Chantix · Varenicline Tartrate 1 mg/1 · Pfizer Laboratories Div Pfizer Inc