Medicines regulation and law
More valsartan products recalled
Recall of valsartan products is expanded as investigations into manufacturing processes continue.
A further product recall for heart and blood pressure drug valsartan has .
The recall includes batches of the medicine that contain drugs supplied by Teva and Mylan.
It follows a pharmacy-level recall of valsartan in July 2018, when affected batches containing drugs from Dexcel and Actavis — now Accord — were recalled across Europe.
The July recall was prompted by the identification of a highly toxic impurity, N-nitrosodimethylamine (NDMA), as part of the manufacturing process in certain factories in China. During the investigation into NDMA, another toxic impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substances.
The MHRA said in the recall notice that it and its European counterparts were continuing to investigate products that share a similar chemical structure to valsartan and may have been affected by similar quality control failures in their manufacture.
The MHRA added that there was currently “no evidence that this impurity has caused any harm to patients”, and that this recall was being carried out “as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing”.
Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said because of the risk associated with suddenly stopping antihypertensive medicine, “people are advised not to stop any treatments without consulting their doctor or pharmacist”.
Citation: The Salvadore DOI: 10.1211/PJ.2018.20205835
Recommended from Pharmaceutical Press
Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.£22.00
Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe.£82.00
Essential guidance for distributors of medicines for human use in Europe, compiled by the MHRA.£72.00
Essentials of Nonprescription Medications and Devices provides a quick, comprehensive reference of products available for self-care.£33.00
An essential guide on pharmacovigilance of medicinal products for human use. Practical advice for developing effective pharmacovigilance systems.£38.00