Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
Class 2 Medicines Recall: Teva UK Limited and Mylan – recall of some Valsartan containing products – GOV.UK
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.