The Food and Drug Administration has expanded a recall on high blood pressure medications due to potential cancer risk.
This time, Torrent Pharmaceutical Limited is recalling additional lots of Losartan Potassium tablets, which is used to treat hypertension, as well as hypertensive patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients. This expansion is the fifth by Torrent involving Losartan Potassium tablets.
Pills Tainted With Cancer-Causing Chemical
The recall is due to the detection of trace amounts of an unexpected impurity that might cause cancer. The chemical is called NMBA, which is short for N-Nitroso-N-methyl-4-aminobutyric acid.
Beginning in mid-2018, Torrent has now recalled more than 300 lots of blood pressure medication for containing NMBA above the FDA’s acceptable limit.
Torrent is among many other drugmakers that have recalled blood pressure medications with active ingredients coming from suppliers in China and India. Other companies that have announced recalls include Aurobindo Pharma, Camber Pharmaceuticals, GSMS Inc., Legacy Pharmaceuticals, Macleods Pharmaceuticals, Major Pharmaceuticals, Mylan, Prinston Pharmaceuticals, Sandoz Novartis, Teva Pharmaceuticals, and WP Westminster Pharmaceuticals.
Consumers Urged Not to Stop Taking Medication Without Alternative Treatment
The company warns that patients who are taking any of the drugs affected by the recall should not stop taking their medication. The health risk of stopping medication without an alternative treatment may be higher than the risk posed by the contaminant. Patients are urged to instead contact their physician or pharmacist for advice on an alternative treatment.
If consumers have any medical questions regarding the recall or need to report an adverse event, they can contact Torrent Pharmaceuticals Limited at 1-800-912-9561. Torrent also recommends that consumers notify their physician or healthcare provider if they have experienced any problems that could be related to taking this medication.
Identifying Recalled Medication
The pills that are affected by this expanded recall can be identified by checking the medication name, manufacturer details, and batch or lot numbers on the bottles. Here is a list of products affected by the recall:
Losartan Potassium Tablets, USP 50mg, 1000 count
- NDC: 13668-409-10
- Batch Number: 4DU2E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 90 count
- NDC: 13668-115-90
- Batch Number: 4DU3E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 1000 count
- NDC: 13668-115-10
- Batch Number: 4DU3D018
- Expiration: 02/28/2021
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg /12.5mg, 90 count
- NDC: 13668-116-90
- Batch Number: BEF7D051
- Expiration: 11/30/2020
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count
- NDC: 13668-118-90
- Batch Number: 4P04D007
- Expiration: 07/31/2020