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Valsartan batches recall

Possible carcinogen contaminant

December 4th 2018

Tagged: MHRA alert

By Ailsa Colquhoun

Teva and Mylan are recalling specific batches of valsartan due to possible contamination with the carcinogenic and genotoxic substance N‑nitrosodiethylamine (NDEA).

Teva is recalling specific batches of the following items:

  • Valsartan 320mg Film-coated Tablets
  • Valsartan 40mg Film-coated Tablets
  • Valsartan / Hydrochlorothiazide 80 / 12.5mg Film-coated Tablets
  • Valsartan / Hydrochlorothiazide 160 / 12.5mg Film-coated Tablets
  • Valsartan / Hydrochlorothiazide 160 / 25mg Film-coated Tablets

Mylan is recalling five batches of valsartan capsules and tablets in various strengths.

Download the affected batch information.

Dispensaries are advised to:

  • Stop supplying the above products / batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.

Company information

Teva
For stock control, email: general.enquiries@tevauk.com

For medical information, email: medinfo@tevauk.com

Mylan
For stock control: mguk_customer.services@mylan.co.uk, 01707 853100

For medical information enquiries:info@mylan.co.uk, 01707 853 000, Option 1

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