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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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A Resized Recall Image cb1July 5 2018

A Class 1 drug alert for the immediate recall of all valsartan products made by Actavis Group PTC (now Accord) and Dexcel Pharma has been issued.

The MHRA issued the recall at 4pm on July 5 due to concerns about possible product contamination with an impurity N-nitrosodimethylamine (NDMA). This has genotoxic and carcinogenic potential.

“This is an emerging issue; the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact,” said the MHRA.

The products listed in the recall are:

  • the three strengths of valsartan (40mg, 80mg and 160mg) hard capsules from Dexcel Pharma.
  • the four strengths of valsartan (40mg, 80mg, 160mg and 320mg) film-coated tablets from Actavis Group.

An email alert issued by the MHRA also mentions valsartan products made by Aptil Pharma Limited (now Torrent), although this was not mentioned on the main recall notice at 5pm.

Healthcare professionals have been asked to: 

  • stop supplying the products listed above immediately;
  • quarantine all remaining stock for return to the supplier;
  • if asked by patients, encourage patients not to stop taking their medication but to speak to their doctor to help identify alternatives.

Company contacts given in the Drug Alert are:

  • for Dexcel products: Cheryl Haynes via or tel: 01327 314830
  • for Actavis products: the Customer Services Team on 0800 373573 or Accord Medical Information on 01271 385257

Link:
MHRA Class 1 Drug Alert           

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