Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
Reported: September 29, 2021 Initiated: August 13, 2021 #D-0811-2021
Product Description
Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Details
- Recalling Firm
- Pfizer Inc.
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023. Recalled by Pfizer Inc..
Why was this product recalled? ▼
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0811-2021.
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