The company is recalling 14 lots of tablets used for treatment of high blood pressure and heart failure from the US market due to presence of impurity
The voluntarily recall of Valsartan/Amlodipine/HCTZ tablets to the consumer level is due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals, Torrent Pharma said in a release posted on the website of US health regulator FDA (Food and Drug Administration).
“The impurity detected in the API is N-nitrosodimethylamine (NDMA), which has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification,” it added.
NDMA occurs naturally in certain foods, drinking water, air pollution, and industrial processes, the release said.
“To date, Torrent Pharmaceuticals Ltd has not received any reports of adverse events related to this recall,” it added.
Valsartan/Amlodipine/HCTZ tablets were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers, the release said.
“Torrent Pharmaceuticals Ltd 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,” it added.
The company is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter, it added.