Manufactured by the Chinese pharmaceutical company Zhejiang Huahai, Valsartan contains the chemical N-nitrosodimethylamine, or NDMA, which has recently been found to cause cancer in humans, FDA says.
The agency originally recalled select lots of Valsartan last month, and has since twice expanded the action to include drugs made by other companies, as well as some tablets with valsartan and hydrochlorothiazide (HCTZ).
The Valsartan recall has spread across the globe, with Health Canada and the European Medicines Agency (EMA) having also recalled Chinese-sourced products.
In the U.S., FDA has recalled valsartan-containing products from the following companies:
- A-S Medication Solutions (labeled as Solco Healthcare)
- Bryant Ranch Prepack
- HJ Harkins Company
- Northwind Pharmaceuticals
- Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
- Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)
- AvKARE
- A-S Medication Solutions
- Northwind Pharmaceuticals
- Prinston Pharmaceutical (labeled as Solco Healthcare)
- Proficient Rx
- Remedy Repack
- Teva Pharmaceuticals (some labeled as ACtavis)
FDA advises consumers who are taking a medication with valsartan to compare their prescription bottle to the agency’s list to determine whether their drugs have been recalled. Patients can also contact their pharmacist, who may be able to provide valsartan from a pharmaceutical company not involved in the recall.
Patients taking these medications should continue using them until their doctor or pharmacist has a replacement drug or treatment, FDA says.
Source: CNN