- Mylan has expanded its nationwide voluntary recall of tablets containing valsartan to cover all batches, saying Tuesday it will add an additional 104 lots to those already taken off the market. All distributors and customers will be contacted by letter, and Mylan is arranging for the return of all recalled products.
- The withdrawal of the high blood pressure medication is a response to the finding of trace amounts of a potential carcinogen, N-nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. These batches were distributed in the U.S. between March 2017 and November 2018.
- The valsartan issue has affected a number of different drug companies, and the Food and Drug Administration and the European Medicines Agency are carrying out investigations.
Scrutiny into valsartan manufacturing has been developing since mid-2018, when the FDA and EMA backed a voluntary recall of batches of valsartan tablets that contained API produced by the Chinese manufacturer Zhejiang Huahai.
These were contaminated with the potential carcinogen N-nitrosodimethylamine (NDMA). An inspection of the company's Linhai site by the EMA found it to be in non-compliance with good manufacturing practices, and Zhejiang Huahai's Chuannan site received a Form 483 from the FDA.
The Linhai site is no longer authorized by the EMA to produce valsartan for EU medicines, and all imports into the U.S. from the company have been banned by the FDA. After finding traces of NDMA in the API, the EMA has also withdrawn authorization from a second Chinese company, Zhejiang Tianyu, to manufacture valsartan.
From NMDA, the story spread to NDEA, or N-nitrosodiethylamine, another potential carcinogen. In September, the FDA's testing revealed NDEA contained in API from Zhejiang Huahai.
Mylan began its withdrawals because of NDEA in November, recalling 15 lots of valsartan, valsartan/amlodipine and valsartan/hydrochlorothiazide tablets. This was followed in the same month by Teva Pharmaceuticals' withdrawal of all lots of valsartan-containing products manufactured using API from Mylan.
In October, Reuters reported that valsartan has been in shortage since August. This is likely to worsen with the withdrawals by Teva and Mylan. That report stated the price of an 80 mg and 160 mg tablet more than doubled between August and September.
Valsartan is a widely-used medication for elevated blood pressure, and these widespread withdrawals could increase the risk of shortage and problems accessing the medication.