Drug-maker Torrent Pharmaceuticals Ltd (TPL) on informed about recall of certain lots of its high blood pressure heart disease control drug in the US market.
A TPL statement released by the US Food and Drug Administration (USFDA) stated that the company voluntarily recalled 14 lots of Valsartan/ amlodipine/ HCTZ tablets to the consumer level. The move comes after “detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.”
“The impurity detected in the API is N-nitrosodimethylamine (NDMA), 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,” the statement said.
However, there are no reports of adverse events related to the recall so far.
Valsartan, in combination with amlodipine plus hydrochlorothiazide, is used to control high blood pressure. “Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the statement added further.
Valsartan/Amlodipine/HCTZ tablets were distributed across the US to Torrent’s wholesale, distributor, repackager and retail customers.
The company is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.
