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Pfizer recalling popular stop-smoking drug Chantix over impurities – Portland, Oregon

Portland, Oregon 2021-07-19 18:54:30 –

Chantix (Credit: FDA)

(NEXSTAR) — Pfizer voluntarily Recalling the smoking cessation drug Chantics Due to impurities above approved levels, the Varenicline brand, Food and Drug Administration, has announced.

The recall includes 2 lots of Chantix 0.5 mg tablets, 2 lots of Chantix 1 mg tablets, and 8 lots of Chantix kits of 0.5 mg / 1 mg tablets that may be too high in nitrosamines and N-nitroso-varenicline. Daily intake (ADI) levels established by Pfizer.

“N-nitroso-valenicline belongs to the nitrosamine class of compounds, some of which are human carcinogens (substances that can cause cancer), based on laboratory tests such as rodent carcinogenicity studies. It will be categorized, “says the FDA.

The FDA states that there is no immediate risk to patients taking this drug, but long-term use “may be associated with a theoretical potential increase in human cancer risk.” However, the FDA states that the health benefits of smoking cessation outweigh the risk of cancer from impurities in varenicline.

Chantix helps smokers quit smoking and is intended for short-term use. According to the FDA, smokers are 15 to 30 times more likely to develop lung cancer than nonsmokers.

The FDA said everyone was exposed to some degree of nitrosamines. Nitrosamines are commonly found in water and foods such as salted and roasted meats, dairy products, and vegetables.

“These impurities can increase the risk of cancer if people are exposed to them beyond acceptable levels over a long period of time,” the FDA said.

People taking Chantics should check with their doctor to see if they have received the affected lot and, if appropriate, alternative treatments. Pfizer has not received any reports of “adverse events” associated with this recall.

The FDA has provided the following table with domestic drug code (NDC), lot number, expiration date, and configuration details for Chantix tablets. Product lots were distributed to the United States and Puerto Rico from June 2019 to June 2021.

Product NDC Lots ExpDate presentation Configuration / Count
Chantics
(Varenicline)
Tablets, 0.5 mg
0069-0468-56 00019213 January 2022 Bottle 56 tablets / bottle
Chantics
(Varenicline)
Tablets, 0.5 mg
0069-0468-56 EC6994 May 2023 Bottle 56 tablets / bottle
Chantics
(Varenicline)
Tablets, 1 mg
0069-0469-56 EA6080 March 2023 Bottle 56 tablets / bottle
Chantics
(Varenicline)
Tablets, 1 mg
0069-0469-56 EC9843 March 2023 Bottle 56 tablets / bottle
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 00020231 September 2021 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 00020232 November 2021 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 00020357 December 2021 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 00020358 January 2022 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 00020716 January 2022 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 ET1600 January 2023 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 ET1607 January 2023 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantics
(Varenicline)
Tablets, 0.5 / 1 mg
0069-0471-03 ET1609 January 2023 Carton containing two blister packs A carton containing one blister pack containing 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets

For more information, please visit. FDA website..

Pfizer recalling popular stop-smoking drug Chantix over impurities Source link Pfizer recalling popular stop-smoking drug Chantix over impurities

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