Pfizer Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets recall — FDA D-0808-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Subpotency: one product for active ingredient assay and another one for preservative assay
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Subpotency: one product for active ingredient assay and another one for preservative assay
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
CGMP Deviations
Failed Dissolution Specifications
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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