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Pfizer Expands Recall to Twelve Lots of Chantix Tablets americanpharmaceuticalreview
July 22, 2021
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline ...
US FDA releases guidance to detect and prevent nitrosamines in drugs expresspharma
September 03, 2020
The US Food and Drug Administration (US FDA) has published guidance ‘Control of Nitrosamine Impurities in Human Drugs’ for immediate implementation.
EMA announces update on nitrosamine impurities in medicines europeanpharmaceuticalreview
March 05, 2020
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
Statement from the FDA on NDMA found in drugs outside the US europeanpharmaceuticalreview
December 10, 2019
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
New generic valsartan approved to address shortages europeanpharmaceuticalreview
April 12, 2019
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers…