Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Medicines regulation and law

More valsartan products recalled

Recall of valsartan products is expanded as investigations into manufacturing processes continue.

Valsartan packet


The further recall of valsartan follows a pharmacy-level recall in July 2018, when affected batches were recalled across Europe

A further product recall for heart and blood pressure drug valsartan has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

The recall includes batches of the medicine that contain drugs supplied by Teva and Mylan.

It follows a pharmacy-level recall of valsartan in July 2018, when affected batches containing drugs from Dexcel and Actavis — now Accord — were recalled across Europe.

The July recall was prompted by the identification of a highly toxic impurity, N-nitrosodimethylamine (NDMA), as part of the manufacturing process in certain factories in China. During the investigation into NDMA, another toxic impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substances.

The MHRA said in the recall notice that it and its European counterparts were continuing to investigate products that share a similar chemical structure to valsartan and may have been affected by similar quality control failures in their manufacture. 

The MHRA added that there was currently “no evidence that this impurity has caused any harm to patients”, and that this recall was being carried out “as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing”.

Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said because of the risk associated with suddenly stopping antihypertensive medicine, “people are advised not to stop any treatments without consulting their doctor or pharmacist”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205835

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Valsartan packet

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.