Torrent Pharmaceuticals is voluntarily recalling all lots within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the 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.
To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
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Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it 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 products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
Valsartan/Amlodipine/HCTZ. Valsartan/Amlodipine and Valsartan tablets were distributed Nationwide to Torrent's wholesale, distributor, repackager and retail customers. Torrent Pharmaceuticals Limited 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. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter. The complete list of recalled products can be found on the FDA website.