Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Reported: August 11, 2021 Initiated: June 9, 2021 #D-0700-2021
Product Description
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 350,985 cartons
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.. Recalled by Pfizer Inc.. Units affected: 350,985 cartons.
Why was this product recalled? ▼
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 11, 2021. Severity: Moderate. Recall number: D-0700-2021.
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