WASHINGTON – The Food and Drug Administration has again expanded a recall for medication used to treat high blood pressure over contamination with a chemical linked to cancer.
Torrent Pharmaceutical Limited is recalling certain lots of Losartan Potassium tablets. The medication is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in Type 2 diabetic patients, according to the FDA.
The recall notice said trace amounts of an impurity called N-methylnitrosobutyric acid (NMBA) have been detected in the medicine. The impurity can cause cancer and is the reason behind similar recalls of blood pressure medication over the last year.
For now, patients should continue to use the medication. That’s because the health risk of stopping it immediately without any alternative treatment may be higher. Patients should contact their pharmacist or doctor to learn about alternatives.
The recall includes the following medications:
Losartan Potassium Tablets, USP 50mg, 1000 count
- NDC: 13668-409-10
- Batch No.: 4DU2E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 90 count
- NDC: 13668-115-90
- Batch No.: 4DU3E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 1000 count
- NDC: 13668-115-10
- Batch No.: 4DU3D018
- Expiration: 02/28/2021
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
- NDC: 13668-116-90
- Batch No.: BEF7D051
- Expiration: 11/30/2020
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count
- NDC: 13668-118-90
- Batch No.: 4P04D007
- Expiration: 07/31/2020
Anyone with questions regarding the recall or who wants to report an adverse reaction to the drug should contact Torrent Pharmaceuticals Limited at (800) 912-9561 (live calls received between 8 a.m. and 5 p.m. Eastern; voicemail available 24 hours a day, seven days a week).
