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11 July 2018 by Hilary Cunningham

Class 1 Medicines recall: Valsartan 40mg, 80mg, 160mg, 320mg, Valsartan/ Hydrochlorothiazide 160/12.5mg

  • Wales
  • England
  • Scotland
  • Northern Ireland

Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord), Aptil Pharma Limited (now Torrent) and Dexcel Pharma Ltd due to contamination.

Brief description of the problem

All batches of the above products are being recalled at a European level due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product details

Product Name

Marketing Authorisation Holder

PL number

VALSARTAN 40MG CAPSULES, HARD

DEXCEL PHARMA LIMITED

PL 14017/0192

VALSARTAN 80MG CAPSULES, HARD

DEXCEL PHARMA LIMITED

PL 14017/0193

VALSARTAN 160MG CAPSULES, HARD

DEXCEL PHARMA LIMITED

PL 14017/0194

VALSARTAN 40MG FILM-COATED TABLETS

ACTAVIS GROUP PTC EHF

PL 30306/0109

VALSARTAN 80MG FILM-COATED TABLETS

ACTAVIS GROUP PTC EHF

PL 30306/0110

VALSARTAN 160MG FILM-COATED TABLETS

ACTAVIS GROUP PTC EHF

PL 30306/0111

VALSARTAN 320MG FILM-COATED TABLETS

ACTAVIS GROUP PTC EHF

PL 30306/0405

VALSARTAN/HYDROCHLOROTHIAZIDE 160/12.5MG TABLETS

ACTAVIS GROUP PTC EHF

PL 30306/0342

Healthcare professionals and wholesalers

Stop dispensing the products listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. An investigation into other potentially impacted products is currently being undertaken and further updates will be provided as the investigation progresses.

Company contacts for further information

Dexcel:

Cheryl Haynes – Responsible Person

cheryl.haynes@dexcel.com

Telephone: 01327 314830 or 07827 895061

Actavis (now Accord):

For Actavis stock control: Customer Services Team on 0800 373573

For medical information enquires please contact Accord Medical Information on 01271 385257

To access the full recall https://assets.publishing.service.gov.uk/media/5b3e325de5274a37707745fa/EL_18_A_11-_revision_1.pdf

NumarkNet Drug-Alert-1.png

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