August 10, 2018
European and US health officials are expanding their recall of valsartan after the potentially cancer-causing substance, N-nitrosodimethylamine (NDMA), was detected in some valsartan medications made by a second Chinese drug maker and by a drug maker in India.
More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent weeks after NDMA was discovered in the active pharmaceutical ingredients (API) manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.
The second company now identified is Zhejiang Tianyu Pharmaceuticals, Taizhou, China.
"The NDMA levels detected in batches of valsartan from Zhejiang Tianyu is much lower than levels seen in the active substance from Zhejiang Huahai, which triggered a recall of several valsartan medicines in July 2018," the European Medicines Agency (EMA) said in an August 10 statement.
A list of medicines containing valsartan from Zhejiang Tianyu will be available from national medicines authorities.
The EMA said it is working with international partners to review the impact of the NDMA detected in valsartan from Zhejiang Tianyu but that "there is no immediate risk to patients."
The US Food and Drug Administration announced recalls yesterday of some valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals, after they were also found to contain NDMA.
"Test results from Hetero Labs shows the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang," the FDA said in its August 9 update.
The agency said it is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and to help inform the ongoing investigation.
The FDA has also contacted other manufacturers of valsartan API to determine whether their manufacturing processes are at risk for the formation of NDMA and is working with them to ensure NDMA is not present in future valsartan API.
The FDA and other health officials believe the presence of NDMA in the widely used heart drug is related to changes in the way the active ingredient was manufactured by Zhejiang Huahai.
"Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals," the FDA update said.
Although not all Camber valsartan products distributed in the United States are being recalled, the FDA said recalled valsartan products labeled as Camber may be repackaged by other companies.
The FDA will provide future updates on the new recall and maintains an updated list of valsartan products under recall and a list of valsartan products not under recall.