Torrent Pharmaceuticals Limited has expanded its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets for all consumers.
The FDA reported that traces of unexpected impurities, N-Methylnitrosobutyric acid (NMBA), were found in batches manufactured with active pharmaceutical ingredients.
Losartan is used to treat patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetics.
The products included in the expanded recall are listed below:
NDC Product Name, Strength and Package Count Batch Number Expiration Date
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E018 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04D007 07/31/2020
This is the 5th expansion recall for the drugs.
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.
Officials urge patients to contact their health physician or pharmacist to receive alternative treatment before returning their medication. Consumers should also contact a doctor if they have experienced any health issues that may be related to these drugs.