Quality Systems

Articles

Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.

Testing for Nitrosamines in Pharmaceutical Drugs

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.


CHMP Recommends Suspension of All Ranitidine Medicines in the EU

The company is recalling the product because of out-of-specification results for high molecular weight polymers.

B. Braun Medical Inc. Recalls Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container

The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.

Fresenius Kabi Recalls Ketorolac Tromethamine Injection, USP

The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.

Avet Pharmaceuticals Recalls Tetracycline HCl Capsules USP, 250 mg and 500 mg

The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination. 

Amneal Pharmaceuticals Recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL)

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.

PRAC Recommends Suspension of Ulipristal Acetate for Uterine Fibroids

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.


EU Regulators are Closely Monitoring Potential Impact of COVID-19 on Supply

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

European Authorities Continue Work to Prevent and Manage Nitrosamine Impurities

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.


Adverse Events and Recalls