Class 2 MHRA Medicines Recall: Valsartan containing products (Teva UK Limited and Mylan)

Class 2 MHRA Medicines Recall: Valsartan containing products (Teva UK Limited and Mylan)

November 30, 2018

Drug alert number: EL (18) A/17 issued 30th November 2018 

Further to Drug alert number: EL (18) A/11, issued in July 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of Valsartan containing products. 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.

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.

Community pharmacy teams should stop supplying the above products/batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

To view the alert please visit the GOV.UK website.

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



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