The Food and Drug Administration has once again expanded its recall of widely prescribed blood pressure drugs after trace amounts of a chemical linked to cancer was detected during testing.
The latest recall, announced Monday, targets five additional lots of the drug losartan sold by Torrent Pharmaceuticals. The lots include losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets.
The affected batches are listed below. The products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products:
- 13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count. Batch number: 4DU2E009. Expiration date: 12/31/2020
- 13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count. Batch number: 4DU3E009. Expiration date: 12/31/2020
- 13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count. Batch number: 4DU3E018. Expiration date: 02/28/2021
- 13668-116-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count. Batch number: BEF7D051. Expiration date: 11/30/2020
- 13668-118-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Batch number: 4P04D007. Expiration date: 07/31/2020
The FDA said tests detected higher-than-acceptable level of N-Methylnitrosobutyric acid, or NDMA, a known carcinogen.
Losartan is a generic angiotensin II receptor blocker, or ARB, and is used to treat high blood pressure, left ventricle-heart conditions and nephropathy in Type 2 diabetic patients, among other conditions. Losartan potassium and hydrochlorothiazide tablets are also used to treat high blood pressure and heart issues
Over the last year, scores of batches of generic ARBs have been withdrawn from the market due to the presence of different potential contaminants. The latest recall is the fifth expansion by the FDA of Torrent's losartan.
Consumers taking the affected medication should speak with their doctors to discuss the recall before they stop taking the drug, or if they have experienced any adverse effects that may be related to the drug.
Anyone with questions about the latest recall or to report an adverse even related to the affected products may call Torrent Pharmaceuticals at 1-800-912-9561 24 hours a day, seven days a week.