Torrent Pharmaceuticals Limited is increasing its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer stage as a result of detection of hint quantities of an unexpected impurity while testing the below completed product batches manufactured utilizing active pharmaceutical ingredient (API) made by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include a further three numerous Losartan Potassium Tablets USP and two numerous Losartan Potassium/Hydrochlorothiazide Tablets, USP.
The impurity detected is N-Methylnitrosobutyric acid (NMBA). Torrent is simply recalling plenty of losartan-containing merchandise that comprise N-Methylnitrosobutyric acid (NMBA) above the suitable each day consumption ranges launched by the FDA.
Losartan medicine is used for the treatment of hypertension, hypertensive patients with Left Ventricular Hypertrophy, also the treatment of Type 2 diabetic patients. Losartan Potassium as well as Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.
Patients who’re taking Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP should proceed to take their medicine, as the chance of harm to the patient’s health may be higher if the treatment is stopped immediately without any different treatment. Patients must contact their pharmacist or physician who can guide them about alternative therapy before returning their medication.
The product might be recognized by checking the product name, manufacturer details, and batch or lot number on the bottle containing these products. Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP had been sold nationwide to Torrent companies wholesale distributor, and retail buyers. Torrent Pharmaceuticals Limited is notifying its distributors including customers by telephone and in writing to instantly discontinue distribution of the precise lots being recalled and to tell their sub-accounts. Torrent is preparing for the return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.