FDA Announces New Recommendations for Acceptable Limits of Nitrosamine in Drugs
Guidance comes after a number of massive drug recalls issued in recent years due to nitrosamine contamination, which could increase cancer risks.
Tag Archives: Nitrosamines
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Plans to Remove Potentially Carcinogenic Contaminants from Januvia, Janumet Outlined By Merck
Merck indicates it has identified the cause of nitrosamine contaminants in some batches of Januvia and Janumet, which occurs during the manufacturing and storage process.
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Nitrosamines Problems Are More Widespread in Drugs Than FDA Anticipated: Report
The EU and Canada have set daily acceptable limits for all nitrosamines, but the FDA has not. During a meeting this week the U.S. regulators met to discuss how to bets address the problem with nitrosames in drugs.
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Potentially Cancer-Causing Contaminant Found In Januvia: FDA
The cancer-causing contaminant, a nitrosamine, was detected at levels exceeding the daily acceptable allowance set by the FDA, but there will be no recall due to fears of a shortage.
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Accupril Recall Issued Over Nitrosamine Contamination
The Accupril recall is the latest in a string of recalls involving hypertension drugs due to nitrosamine contamination, which could increase the risk of cancer with long-term use.
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Pfizer Announces Accuretic Recall in U.S. Over Nitrosamine Contamination
Similar nitrosamine contamination has led to massive Zantac, Chantix, valsartan and metformin recalls in recent years.
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Accuretic Recall Announced In Canada Over Nitrosamine Contamination In Another Pfizer Hypertension Drug
Patients with recalled Accuretic pills are being told to continue taking the drug until advised otherwise by a healthcare provider.
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Class Action Lawsuit Filed Over Presence of Toxic Chemicals in Chantix
Lawsuits claim the presence of nitrosamines make Chantix an adulterated drug never approved by the FDA.
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Class Action Lawsuit Over Chantix Nitrosamine Impurities Filed Against Pfizer
Cancer causing chemical impurity in Chantix, identified as N-nitroso-varenicline, makes stop-smoking drug an illegally manufactured and distributed medication.
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Chantix Class Action Lawsuit Filed Over Cancer-Causing Impurity
