WASHINGTON - Torrent Pharmaceuticals is expanding its recall for Losartan Potassium Tablets and Losartan Potassium/hydrochlorothiazide tablet due to the detection of trace amounts of an unexpected impurity.

According to the Food and Drug Administration, the recall is expanded to include an additional three lots of Losartan Potassium Tablets USP and two lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected is N-Methylnitrosobutyric acid. Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid above the acceptable daily intake levels released by the FDA.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy, and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking the recalled items should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, according to the manufacturer. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The product/lots included in the expanded recall are listed below. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots

 

Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. 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. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.