Valsartan medicine recalled
The department said Valsartan containing medicines are commonly used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.
PATIENTS who are taking medicines containing the active substance valsartan have been advised to consult their doctors or pharmacist as the medicine has been recalled.
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies are reviewing medicines containing the active substance valsartan, supplied by Zhejiang Huahai Pharmaceuticals, located in Linhai, China.
“This review was triggered because of the detection of an impurity, N-nitrosodimethylamine (NDMA) in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan-containing medicines in South Africa,” South African Health Products Regulatory Authority (SAHPRA) said in a statement.
SAHPRA said not all valsartan-containing medicines are affected and being recalled.
SAHPRA will continue to investigate and assess whether the impurity may pose any risk to patients, and collect more data on the safety of valsartan-containing medicines as it becomes available.
Any new information or recommendations will be communicated to the public.
“While the review is underway, medicines containing valsartan produced by Zhejiang Huahai Pharmaceuticals are being recalled by Pharma Dynamics in collaboration with SAHPRA. Recall letters have already been circulated to healthcare professionals,” SAHPRA said.
The following valsartan-containing medicines are affected and have been recalled:
Dynaval Co 80/12,5 mg, tablet, 44/7.1.3/0018
Dynaval Co 160/12,5 mg, tablet, 44/7.1.3/0019
Dynaval Co 160/25 mg, tablet, 44/7.1.3/0020
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