OR WAIT null SECS
November 09, 2018
Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.
October 23, 2018
Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.
September 27, 2018
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
September 26, 2018
The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.
September 14, 2018
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
September 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
August 28, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.
Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.
August 22, 2018
King Bio is recalling several of its kids and infant products due to possible microbial contamination.