The recalled lots of Chantix were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from May 2019 to September 2021.
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To date, the Company has not received any reports of adverse events related to this recall.
N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
Long-term use of a product containing N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
A preliminary analysis of long-term follow-up data (up to 5 years) involving patients with peripheral arterial disease (PAD) treated with paclitaxel-coated products revealed a ‘potentially concerning’ signal of increased long-term mortality when compared with those treated with uncoated devices, according to the Food and Drug Administration (FDA). Among the 3 trials that included 5-year follow-up…