Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products

Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.

From:
Medicines and Healthcare products Regulatory Agency
Published
30 November 2018
Message type:
Medicines recall/notification
Medical specialty:
Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care, Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
Issued:
30 November 2018

Company name

Teva UK Limited

Valsartan 320mg Film-coated Tablets, PL 00289/1238

Batch number Expiry date Pack size Date of first distribution
100433 28/02/2019 1 x 28 21/06/2017
101777 31/07/2019 1 x 28 15/01/2018

Valsartan 40mg Film-coated Tablets, PL 00289/1235

Batch number Expiry date Pack size Date of first distribution
100350 28/02/2019 1 x 7 01/06/2017
100938 30/04/2019 1 x 7 03/01/2018
101776 31/08/2019 1 x 7 13/09/2018

Valsartan / Hydrochlorothiazide 80 / 12.5mg Film-coated Tablets, PL 00289/1233

Batch number Expiry date Pack size Date of first distribution
6P601163 31/01/2019 1 x 28 23/06/2016
6P606333 30/06/2019 1 x 28 07/10/2016
0001584 31/12/2019 1 x 28 26/04/2017
0002626 31/03/2020 1 x 28 25/08/2017
0002627 31/03/2020 1 x 28 05/07/2017
0003214 30/04/2020 1 x 28 30/10/2017
0004744 31/08/2020 1 x 28 27/12/2017

Valsartan / Hydrochlorothiazide 160 / 12.5mg Film-coated Tablets, PL 00289/1215

Batch number Expiry date Pack size Date of first distribution
6P607166 31/07/2019 1 x 28 07/10/2016
0000426 30/09/2019 1 x 28 13/02/2017
0001520 31/12/2019 1 x 28 04/05/2017
0001521 31/12/2019 1 x 28 25/05/2017
0002298 29/02/2020 1 x 28 16/08/2017
0003663 31/05/2020 1 x 28 27/09/2017
0004670 31/08/2020 1 x 28 11/12/2017

Valsartan / Hydrochlorothiazide 160 / 25mg Film-coated Tablets, PL 00289/1234

Batch number Expiry date Pack size Date of first distribution
6P601084 31/01/2019 1 x 28 19/05/2016
6P606270 30/06/2019 1 x 28 13/09/2016
0000350 30/09/2019 1 x 28 23/01/2017
0000352 30/09/2019 1 x 28 12/04/2017
0001997 31/01/2020 1 x 28 12/06/2017
0002338 29/02/2020 1 x 28 16/08/2017
0003615 31/05/2020 1 x 28 27/09/2017

Mylan

Medline product PL number
Valsartan 40mg Capsules PL 04569/1000
Valsartan 80mg Capsules PL 04569/1001
Valsartan 160mg Capsules PL 04569/1002
Valsartan 40mg Film-coated Tablets PL 04569/1175
Valsartan 320mg Film-coated Tablets PL 04569/1178

Further to Drug Alert number EL (18) A/11, issued in July 2018 in connection with Valsartan containing products contaminated with N-nitrosodimethylamine (NDMA), we have become aware of another nitrosamine contaminant in batches of Valsartan active substance.

This contaminant is N‑nitrosodiethylamine (NDEA), which also has genotoxic and carcinogenic potential. Valsartan containing products from UK suppliers Teva UK Limited and Mylan are affected.

Teva is recalling the listed batches and Mylan is recalling all unexpired batches of the above products from pharmacies as a precautionary measure at a European level due to possible contamination with NDEA.

Healthcare Professionals and wholesalers

  • 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.

  • We do not anticipate any shortages of Valsartan containing products. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments.

This is a developing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for further information

Teva UK Limited

For stock control:general.enquiries@tevauk.com

For medical information enquiries: 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

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

Download document Class 2 Medicines Recall: Teva UK Limited and Mylan - recall Valsartan containing products

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Published 30 November 2018
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