Mylan expands valsartan recall in US

By Flora Southey contact

- Last updated on GMT

(Image: Getty/ugurhan)
(Image: Getty/ugurhan)

Related tags: Mylan, contamination, Carcinogen

Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.

On November 20, Mylan Pharmaceuticals issued a voluntary nationwide recall​ of select lots of high blood pressure medicines, due to the presence of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

NDEA is classified by the International Agency for Research on Cancer​ as a probable carcinogen.

Yesterday, Mylan – which manufactures the API in Hyderabad, India – announced the contamination has prompted the firm to expand its nationwide recall, to now include all lots​ of valsartan tablets, amlodipine and valsartan tablets, and valsartan and hydrochlorothiazide tablets, within expiry.

The additional 104 lots were distributed in the US between March 2017 and November 2018, and are listed here​.

Mylan Laboratories Limited also manufactures valsartan for Teva Pharmaceuticals USA. Last month, the detection of NDEA in the latter’s valsartan-containing medicines prompted Teva to issue a voluntary recall​.

In Europe, authorities have similarly detected NDEA in some batches of Mylan’s valsartan API, and have suspended its use​ in medicines for the region.

Related news

Show more

Related products

How to resolve sticking issues in tablet production

How to resolve sticking issues in tablet production

I Holland Limited - Tabletting Science | 24-Jun-2019 | Case Study

Tablet sticking is one of the most common problems in tablet manufacture. Find out how I Holland used the TSAR scientific predictive model and expert tablet...

How to measure powder and granule flow properties

How to measure powder and granule flow properties

Stable Micro Systems | 01-Apr-2019 | Technical / White Paper

Being able to predict, optimise and control powder flow is of prime importance to manufacturers in ensuring high quality standards. Download this free...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Related suppliers

Follow us

Products

View more