Additional Valsartan-Containing Products Recalled
August 24, 2018 – Torrent Pharmaceuticals has become the latest manufacturer to recall valsartan-containing products due to N-nitrosodimethylamine (NDMA) contamination from an active pharmaceutical ingredient (API) produced by Zhejiang Huahai Pharmaceutical. The recall covers all lots of Torrent’s valsartan, valsartan/amlodipine, and valsartan/amlodipine/hydrochlorothiazide (hctz) tablets within expiry. This is the first recall as a result of NDMA impurity for valsartan products that contain amlodipine.
The recall was issued after testing revealed trace amounts of NDMA contamination in Torrent’s tablets. Unlike previously recalled NDMA-contaminated valsartan products, which included only generics for Novartis’ Diovan® (valsartan) and Diovan® HCT (valsartan/hctz), Torrent’s recall includes generics for Novartis’ Exforge® (valsartan/amlodipine) and Exforge® HCT (valsartan/amlodipine/hctz).
Because these medications are used to treat serious medical conditions, the FDA advises patients to speak with their pharmacist or prescriber before stopping or making any changes to their treatment. Torrent has not received any reports of adverse events connected to the recalled products.
Patients who have medical questions regarding the recall or who wish to report an adverse event can contact Torrent directly, either by phone at 1-800-912-9561 or by email at Medinfo.Torrent@apcerls.com.
In addition, the FDA encourages patients to contact their physician if they may have experienced problems related to the use of valsartan-containing products. Adverse events can also be reported to the FDA’s MedWatch Program.
BeneCard PBF is working with members who may be affected by recalls of valsartan-containing products. A complete list of impacted products, as well as further information regarding these recalls, can be found at the following URL:
General questions regarding returns of Torrent Pharmaceuticals’ recalled valsartan-containing drugs should be directed to Qualanex at 1-800- 505-9291.