Warning letters, 483s, Recalls, Import Alerts, Audit observations
Several lots of the antidepressant drug Duloxetine, manufactured by Aurobindo, India, have been recalled in
Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has
In October 2024, Accord Healthcare recalled over 25 lots of Cinacalcet tablets in various strengths
FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September
Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in
EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15
Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
