FDA expands blood pressure and heart medication recall expanded
The FDA issued a voluntary recall of Losartan potassium tablets Thursday.
In August, the FDA issued a voluntary recall of certain batches of the drug valsartan, which is used to treatand . The recalled drugs were manufactured by Zhejiang Huahai Pharmaceuticals in China and contain a chemical known as N-nitrosodimethylamine (NDMA), which has been shown to increase the occurrence of cancer in animals.
Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
Patients can see a list of the recalled medications, as well as a list of products containing valsartan that have not been recalled, on the FDA’s website.