Class 2 medicines recall – Action within 48 hours: Valsartan containing products
30 Nov 2018
A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for batches of valsartan containing products; these include certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan.
Class 2 medicines recall – Action within 48 hours
Ref: MDR 094-06/18
Date 30 November 2018
Product name Valsartan-containing products
(Manufactured by Teva UK Limited and Mylan)
A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for batches of valsartan-containing products; these include:
- Certain batches supplied by Teva UK Limited
- All unexpired batches supplied by Mylan
The affected batches of valsartan-containing products may be contaminated with a nitrosamine contaminant, N‑nitrosodiethylamine (NDEA) which is potentially carcinogenic and genotoxic.
Advice for pharmacy teams
Pharmacy teams should refer to the recalled batches/products listed on the MHRA website to check their current stock of valsartan-containing products and return to the supplier.
MHRA does not envisage a stock shortage of valsartan-containing products; however, if there are local supply issues, the patient should speak to their prescriber for an alternative.
Advice for patients
Patients should not stop taking their valsartan-containing medicine because the health risk of discontinuing the medicine is greater than the potential risks of the contaminant. The patient should wait until their next routine appointment for a treatment review.
Further information can be found on the MHRA section on the GOV.UK website.
Produced by the NPA Pharmacy team November 2018.