MHRA FDA July 2018 Valsartan

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.

https://www.gov.uk/drug-device-alerts/class-1-medicines-recall-action-now-including-out-of-hours-pharmacy-level-recall#history

 

Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

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

Brief description of the problem

The Drug Alert EL (18)A/11 issued on 5 July 2018 is now superseded by this revised alert EL (18)A/11 – revision 1 because Actavis (now Accord) has provided new information that an additional product (Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets) is also affected and is being recalled. Accord apologises for any inconvenience this may cause.

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.

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.

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 supplying the products 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, encourage them not to stop taking their medication. They should speak to their doctor to help identify alternatives.

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:

  1. Cheryl Haynes – Responsible Person
  2. cheryl.haynes@dexcel.com
  3. Telephone: 01327 314830 or 07827 895061

Actavis (now Accord):

  1. For Actavis stock control: Customer Services Team on 0800 373573
  2. For medical information enquires please contact Accord Medical Information on 01271 385257

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, general practitioners, hospitals and community pharmacists for information.

Download documents

VALSARTAN RECALL

Published 5 July 2018
Last updated 10 July 2018 – hide all updates

  1. An additional product Accord Healthcare (previously known as Actavis Group) manufactured – Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets – is also affected and is being recalled.
  2. First published.
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