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After APIs, Carcinogens NDMA and NDEA Now Impacting Formulations PharmaSources/Dishui Sinan
February 03, 2020
NMPA (CDE) released on its website the Technical Guidelines for the Research of Nitrosamine Impurities in Chemical Drugs (Draft for Comment) on Jan. 10, 2020.
MHRA recalls a further three batches of sartan-based products pharmaceutical-technology
February 14, 2019
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has announced it has recalled three more batches of irbesartan as part of its continued investigation into potential N-nitrosodiethylamine (NDEA) contamination of .....
Torrent Expands its Voluntary Recall of Losartan americanpharmaceuticalreview
January 24, 2019
Torrent Pharmaceuticals is further expanding its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines....
Prinston Issues Recall of Irbesartan, Irbesartan HCTZ Tablets americanpharmaceuticalreview
January 23, 2019
Prinston Pharmaceutical has initiated a voluntary recall of one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in ....
Torrent Pharmaceuticals Issues Recall of Losartan Potassium Tablets americanpharmaceuticalreview
December 24, 2018
orrent Pharmaceuticals is voluntarily recalling two lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of.....
Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets americanpharmaceuticalreview
December 10, 2018
Mylan N.V. announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of .....
Mylan recalls all lots of blood pressure drugs containing valsartan pharmaceutical-technology
December 10, 2018
Mylan has expanded the consumer-level voluntary recall of all lots of valsartan-containing drugs within expiry in the US after finding trace amounts of an impurity called N-nitrosodiethylamine (NDEA).....
Teva Announces Recall americanpharmaceuticalreview
November 29, 2018
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan.....
Aurobindo pharma initiate recall of blood pressure drug Ibesartan pharmafile
November 20, 2018
Indian pharma firm Aurobindo Pharma Ltd has initiated a voluntary recall of 22 batches of blood pressure drug Ibesartan, due to the presence of a probable carcinogen