Warning letters, 483s, Recalls, Import Alerts, Audit observations
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,
Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is
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
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
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
