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Valsartan batches by Teva and Mylan recalled over carcinogen concerns

MHRA: Pharmacies should stop supplying the affected batches “immediately”
MHRA: Pharmacies should stop supplying the affected batches “immediately”

Pharmacies should return batches of valsartan-containing medicine manufactured by Teva UK and Mylan as a “precautionary measure”, the medicines watchdog has announced.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued the recall this morning (November 30), after it became aware of a contaminant in the medicine that has “genotoxic and carcinogenic potential”.

The action followed a recall in July of batches of valsartan-containing medication – used to treat high blood pressure and heart conditions – made by Accord Healthcare and Dexcel Pharma Ltd, after a different impurity was identified in the manufacturing process, which the MHRA said at the time “may have carcinogenic potential”.

The MHRA also said it had discovered the impurity in Teva and Mylan medication during an investigation following the July recall.

The watchdog is investigating sartan products that share a similar chemical structure to valsartan, working with other EU regulators, it added.

It stressed there is “no evidence” the impurity has caused harm to patients.

Dr Sam Atkinson, director of the MHRA’s inspection, enforcement and standards division, said the recall is “a precautionary measure to prevent any further exposure to the impurity in the affected medicines while the investigation continues”.

Quarantine all remaining stock

Pharmacies should stop supplying the affected batches “immediately”, quarantine remaining stock, and return it to the supplier, the MHRA said.

However, they should advise patients “not to stop taking their medication, as the health risk of discontinuing is higher than the potential risk presented by the contaminant”, it added.

“A treatment review is not necessary until the next routine appointment.”

Affected products

Teva UK Ltd

  • Valsartan 40mg and 320mg film-coated tablets
  • Valsartan/hydrochlorothiazide 80/12.5mg film-coated tablets
  • Valsartan/hydrochlorothiazide 160/25mg film-coated tablets

Mylan

  • Valsartan 40mg, 80mg and 160mg capsules
  • Valsartan 40mg and 320mg film-coated tablets

View the list of affected batches for each product here.

1 Comments
Question: 
Do you stock these batches in your pharmacy?

Dave Downham, Manager

Early notice of NCSO price would be useful, thanks

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