The blood pressure medication Losartan Potassium and Hydrochlorothiazide is being pulled from the shelves as it could contain an N-Nitrosodiethylamine impurity that has been classed as a probable human carcinogen.
Losartan Potassium Hydrochlorothiazide USP 25 milligram and 100 milligram tablets, NDC 0781-5207-10, with Lot numbers JB8-912 is the batch of main focus currently. For further information patients can contact the manufacturer Sandoz Inc at 1-800-525-8474.
The drug is used to treat high blood pressure, lower the risk of stroke, and is also sometimes prescribed to treat kidney disease in patients with diabetes.
NDEA has been detected in the active pharmaceutical ingredient, which can be found in drinking water, air pollution, and industrial processes that has been classified as a human carcinogen as per International Agency of Research on Cancer.
Patients should contact their pharmacist and/or physician for advice on alternative treatments prior to returning medication. If adverse reactions or quality problems are being experienced they can be reported at the FDA’s MedWatch Adverse Event Reporting Program at : https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Update: Since initial NDEA announcement recall has been extended to include valsartan-containing products also found to contain traces of N-nitrosodiethylamine impurity from:
https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
- A-S Medication Solutions LLC
- Aurobindo Pharma USA
- AvKARE
- Bryant Ranch Prepack Inc.
- Camber Pharmaceuticals (Hetero Labs)
- H J Harkins Company Inc. (Pharma Pac)
- Mylan Pharmaceuticals
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals
- Preferred Pharmaceuticals
- Prinston Pharmaceutical Inc., including its subsidiary Solco Healthcare LLC
- Proficient Rx LP
- RemedyRepack Inc.
- Teva Pharmaceuticals, including its subsidiaries Major Pharmaceuticals and Actavis
- Torrent Pharmaceuticals Limited
Not all valsartan-containing products are being recalled just those supplied by Zhejiang Huahai Pharmaceuticals and Hetero Labs Limited (Camber Pharmaceuticals).
Patients taking valsartan are urged to talk to their pharmacist and/or health care professional to see if their prescription is included in the recall and to receive a different medication if so as the risks of developing cancer are still unknown.
