NO VALSARTAN medicines sold in Australia have been affected by an issue which has seen a number of recalls issued in Europe and the USA in recent weeks (PD 11 Jul).
The Therapeutic Goods Administration yesterday provided an update on the local situation, confirming that three Chinese manufacturing sites which saw the introduction of a carcinogenic impurity "have not supplied the valsartan active ingredient used in any medicine supplied in Australia".
The TGA contacted the four companies that sponsor products containing valsartan on the Australian Register of Therapeutic Goods, and has subsequently conducted additional verification to reconfirm that no impacted stock has been supplied in Australia.
"While some media headlines and articles regarding the overseas recall actions may have caused concern for Australian consumers, no medicines supplied in Australia are affected," the TGA said.
The problems in Europe and the USA related to an issue at Zhejiang Huahai Pharmaceuticals, with a manufacturing change believed to have led to the introduction of N-nitrosodimethylamine (NDMA) which is classified as a probable human carcinogen.
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