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FDA issues worldwide recall of common blood pressure medication

Published  August 6, 2018 11:18am EDT
News
FOX 13 Tampa Bay
Pills recall generic-401720-401720 article

(FOX 46 WJZY) - A large medication recall has expanded again - now to a global scale. 

Valsartan, a prescription medication commonly used to treat blood pressure issues and heart failure, is now under a worldwide recall. 

The U.S. Food and Drug Administration says the drug contains a cancer causing chemical called N-nitrosodimethylamine (NDMA). This chemical is toxic to the liver and other organs. 

"The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," the FDA said. 

When the initial recall was first announced a few weeks ago, it didn't include the United States and it just impacted the generic version. 

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Now, the recall has gone global with the FDA adding new manufacturers to the list: 

  • Valsartan - Prinston - Pharmaceutical Inc. 
  • Valsartan - AvKARE
  • Valsartan - A-S Medication Solutions LLC
  • Valsartan - Bryant Ranch Prepack, Inc. 
  • Valsartan - HJ Harkins Company 
  • Valsartan - Major Pharmaceuticals
  • Valsartan - Solco Healthcare 
  • Valsartan - Northwind Pharmaceuticals
  • Valsartan - Teva Pharmaceuticals Industries Ltd. 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Proficient Rx LP
  • Valsartan/Hydrochlorothiazide (HCTZ) - Remedy Repack 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Solco Healthcare 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Teva Pharmaceuticals Injustries Ltd. 

For more information on this recall, click here. 

The FDA has also compiled an updated list of medications not included in the recall:

  • Amlodipine and Valsartan - Alembic Pharmaceuticals Limited 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Alembic Pharmaceuticals Limited 
  • Valsartan - Alembic Pharmaceuticals Limited 
  • Byvalson (Nebivolol and Valsartan - Allergan, Inc. 
  • Valsartan - American Health Packaging 
  • Valsartan - Amneal Pharmaceuticals LLC 
  • Diovan and Valsartan  - Aphena Pharma Solutions 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Apotex Corp. 
  • Amlodipine and Valsartan - Aurodindo Pharma Limited 
  • Valsartan  - AcPAK 
  • Valsartan - Cardinal Health 
  • Diovan - Carilion Materials Management 
  • Amlodipine and Valsartan - Gavis Pharmaceuticals, LLC 
  • Valsartan  - Jubilant Cadista Pharmaceuticals Inc. 
  • Valsartan - Lucid Pharma 
  • Amlodipine and Valsartan - Lupin 
  • Valsartan - Macleods Pharmaceuticals USA 
  • Amlodipine and Valsartan - Mylan 
  • Valsartan/Hydrochlorothiazide (HCTZ) - Northwind Pharmaceuticals 
  • Diovan  - Novartis Pharmaceuticals Corp. 
  • Amlodipine and Valsartan - Novel Laboratories, Inc. 
  • Valsartan  - Ohm Laboratories, Inc. 

For more information on various medications that are not included in the recall, click here.