Tag: Nitrosamines

Growing Trend of Drug Recalls for NDSRIs

Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the

NDSRI Nitrosocinacalcet: Aurobindo Recal

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has

Major Recall of Aurobindo’s Anti-Depre

Several lots of the antidepressant drug Duloxetine, manufactured by Aurobindo, India, have been recalled in

NDSRI Nitrosocinacalcet: Aurobindo Recal

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has

Nitrosocinacalcet Nitrosamine Impurity T

In October 2024, Accord Healthcare recalled over 25 lots of Cinacalcet tablets in various strengths

FDA Updates Guideline for Control of Nit

FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September

Risk of Nitrosamines in Rizatriptan and

Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in

EMA Updates list of N-Nitrosamines

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15

EDQM New strategy for N-nitrosamine impu

European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in

Risk of Nitrosamines, NDSRIs, Nitrosamin

Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding