FDA continues to investigate the presence of impurities in valsartan products and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA recently identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain valsartan products. FDA is posting its test results showing NDMA levels in recalled valsartan products. FDA…
FDA Alerts Drug Makers of a Recall of Porcine Thyroid API
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid…
Torrent Pharmaceuticals Issues Voluntary Nationwide Recall
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ 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…
Prinston Pharmaceutical Issues Voluntary Recall Of Valsartan
The FDA is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being…
AuroMedics Pharma Recalls Two Injections
AuroMedics Pharma is voluntarily recalling Ampicillin and Sulbactam for injection and Piperacillin and Tazobactam for injection. Ampicillin and Sulbactam for Injection AuroMedics Pharma announced a recall of two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of…