Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Glenmark Recalls Over 1.5 Million Bottle

Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,

NDSRIs: Glenmark Recalls Several Lots of

Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to

One More Drug Recall for NDSRI From Glen

Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is

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