Regulatory Guidance

FDA widens generic drug recall probe beyond heart meds

Aug 28, 2019

The FDA is reportedly expanding its investigation related into impurities found in a class of blood pressure medications.

Last year, the agency triggered a recall for several angiotensin II receptor blockers (ARBs) such as valsartan, due to the presence of a chemical contaminant that has been linked to cancer. Now the FDA says it is looking into other classes of drugs that have a similar manufacturing process for potential impurities. The agency did not specify which class of drugs specifically it’s testing. 

The initial recall of blood pressure medications happened after the cancer-causing toxins were found in APIs used by Zhejiang Huahai Pharmaceuticals Co. in China. Since then, the recall has impacted a number of major companies including Teva and Novartis’ Sandoz.

Read the Reuters report.