Chantix recall: Impurity Out of Spec
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
Why was Chantix recalled?
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
- 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
- Recalling firm
- Pfizer Inc.
- Quantity
- 59,232 bottles
- Distribution
- Nationwide
- Recall date
- August 11, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)