Class 1 MHRA drug alert – Valsartan and Valsartan/ Hydrochlorothiazide

Class 1 MHRA drug alert – Valsartan and Valsartan/ Hydrochlorothiazide

July 10, 2018

Drug alert number: EL (18)A/11

Date first issued: 5th July 2018 (update made on 10th July)

The Medicines and Healthcare products Regulatory agency (MHRA) has issued a class 1 pharmacy level recall for certain batches of:

Valsartan 40mg, 80mg and 160mg capsules (Dexcel Pharma Ltd) and 40mg, 80mg, 160mg and 320mg tablets (Actavis Group PTC EHF)

Update 10th July: An additional product Accord Healthcare manufactured – Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets – is also affected and is being recalled.

Batches of the above products are being recalled from pharmacies as a precautionary measure due to possible contamination with an impurity which has genotoxic and carcinogenic potential.

Healthcare professionals and wholesalers are instructed to stop supplying the affected batches immediately and quarantine all remaining stock and return it to the supplier.

To view the alert, please visit the Central Alerting system website.



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