The recall from Torrent includes 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets to the consumer level, after the possibly carcinogenic impurity N-Methylnitrosobutric acid (NMBA) was found in the tablets’ active pharmaceutical ingredient (API). Teva also initiated a recall of its losartan potassium tablets, 35 lots of the medicine, also due to the detection of NMBA in its API.
Hetero Labs, a pharmaceutical manufacturing company based in Hyderabad, India, produced all 104 lots of API for Torrent Pharmaceuticals and Teva's medicine.
Recently, sartan based products such as valsartan and losartan have been recalled due to the detection of impurities of NMBA, N-nitrosodiethylamine (NDEA), and N-nitrosodimenthyamine (NDMA).
To date, neither Teva nor Torrent have received any reports of adverse events related to this recall.
Investigations into the cause of the impurities in sartan products are underway from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Most recently, the EMA stated it had drawn conclusions as to the cause and is working to find solutions to identify and avoid further contamination of sartan products.
Due to the frequent recalls of sartan products, the FDA prioritized a generic of valsartan from Alkem Laboratories in an attempt to alleviate any shortages that may occur.