The FDA has expanded its recall of tainted valsartan products to include certain lots of valsartan hydrochlorothiazide.

The FDA recalled particular batches of valsartan in July 2018 because of possible contamination with a carcinogen. Patients with high blood pressure and heart failure are apt to be prescribed valsartan, an angiotensin II receptor that prevents blood vessels from narrowing. Unrestricted blood vessels enable blood pressure to lower and increases circulation.

Valsartan is the generic name of brand name medication Diovan, which is made by Novartis International AG. Diovan and several generic versions made by a variety of companies are not part of the valsartan or valsartan hydrochlorothiazide recall.

Hydrochlorothiazide is a diuretic added to valsartan when a patient is in need of it, too.

The FDA originally recalled generic valsartan medication made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd and valsartan hydrochlorothiazide made by both Solco and Teva. All of these medications were provided with the active pharmaceutical ingredient by Zhejiang Huahai Pharmaceuticals in China.

The updated recall includes valsartan and valsartan hydrochlorothiazide made by Hetero Labs Limited in India, which is labeled as Camber Pharmaceuticals Inc. The FDA notes that not all of Camber’s valsartan and valsartan hydrochlorothiazide products distributed throughout the U.S. are under recall.

Camber is recalling certain tablets because they contain the same impurity originally found in the Zhejiang active pharmaceutical ingredient.

Test results from Hetero Labs show the amount of contaminant NDMA in its valsartan active pharmaceutical ingredient exceeds U.S. acceptable levels but is “generally lower” than the amount determined in the Zhejiang-produced medications.

Also added to the recalled product list are repackaged valsartan and valsartan hydrochlorothiazide products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. labeled as A-S Medication Solutions LLC, AvKARE, and RemedyRepack. Some of the valsartan-based medications made by A-S Medication Solutions and RemedyRepack might not be affected by the recall.

Other repackagers of valsartan and valsartan hydrochlorothiazide that were originally excluded from the recall list but are now expected to be issuing recalls as well include:

• Bryant Ranch Prepack Inc.
• J. Harkins Company Inc. (this company was not originally included on either list)
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx

Valsartan and Valsartan Hydrochlorothiazide Recalls Due to Contamination

These recalls of valsartan and valsartan hydrochlorothiazide medications are not due to any adverse effects linked to the medications themselves, but to a contamination in their creation.

A chemical called N-nitrosodimethylamine (NDMA) has been found in certain batches of valsartan-based medications. The Environmental Protection Agency considers NDMA a probable human carcinogen, which means it is a chemical that can increase the risk of cancer.

Finding NDMA in the medications was unexpected, and the FDA believes the presence of the carcinogen is due to a change in the way the active pharmaceutical ingredient was manufactured. NDMA can be a byproduct of some manufacturing processes.

The FDA recommends patients taking valsartan or valsartan hydrochlorothiazide from a recalled batch continue to take it until their doctor or pharmacist finds a replacement or even an alternative treatment option.