OR WAIT null SECS
April 22, 2020
The company is recalling the product because of out-of-specification results for high molecular weight polymers.
The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.
April 17, 2020
The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.
April 16, 2020
The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination.
March 18, 2020
The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.
March 13, 2020
EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.
March 06, 2020
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.
March 02, 2020
Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.
A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.