The drug regulator inspected all valsartan that was locally produced or imported to Korea and found that some batches that had been produced by Daebong LS (KOSDAQ: 078140) contained over 0.3 ppm of
N-nitrosodimethylamine (NDMA), a chemical that at high levels can increase the risk of cancer.
That impurity,
N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen, based on results from lab tests.
Based on reports from the European Medicines Agency (EMA), these medications were found to contain significant amounts of an impurity,
N-nitrosodimethylamine (NDMA) that may cause cancer.
The results show that
N-Nitrosodimethylamine (NNDMA) is not detected in their Valsartan ensures adequate safety and conforms to the regulatory requirement.
The recall of the medicines came at the pointation of the European Medicine Agency (EMA) in the wake of the detection of
N-nitrosodimethylamine (NDMA) - a cancer-causing impurity - in the Valsartan active substance.
The Pharmacy and Drug Control Department at the ministry said it received memos from international organisations on the possibility of a carcinogenic flaw called
n-nitrosodimethylamine (NDMA) in the active substance (Valsartan) manufactured by the company.
The Pharmacy and Drug Control department at the ministry said it received memos from international organisations on the possibility of a "carcinogenic flaw" called
n-nitrosodimethylamine (NDMA) in the active substance Valsartan manufactured by the company.
The recall came after the detection of a chemical -
N-Nitrosodimethylamine - that could lead to cancer.
This recall is a precautionary measure taken by the ministry following a report issued by the European Medicines Agency indicating the detection of a contamination of the active ingredient with
N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer.
This recall is a precautionary measure taken by the Ministry following the report issued by the European Medicines Agency indicating the detection of a contamination of the active ingredient with
N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer.
The one-off, emergency measure reflected fury from the patients, whose health conditions require a long-term intake of the drug, following reports that the Chinese-made Valsartan contained
N-nitrosodimethylamine (NDMA), a key ingredient in high blood pressure drugs.
The affected products, which were manufactured by China's Zhejiang Huahai Pharmaceutical, contained
N-nitrosodimethylamine (NDMA) -- a chemical that might lead to cancer.