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The drug against heart containing valsartan is recalled in South Africa after an impurity was discovered in one of the manufacturing plants in China, which produces the molecule for pharmaceutical companies of the world whole. SAHPRA) this week has confirmed the recall of certain drugs containing the active pharmaceutical ingredient, valsartan.
"The molecule has been recalled in several international markets including the US and Europe as the origin of many generic suppliers and valsartan of the same manufacturer" a statement issued Thursday by the public relations company Meropa on behalf of Pharma Dynamics, South Africa's leading provider of cardiovascular drugs.
"The presence of the impurity could be related to changes in the way the active substance was manufactured, currently being made to determine the exact cause."
The statement says SAHPRA w Malade continue to Investigate and evaluate if the impurity may pose a risk to patients and collect more data on the safety of drugs containing valsartan. The molecule, which has been on the South African market for 21 years, is used worldwide to treat cardiovascular disease.
"At this stage, no definitive information has been received indicating an immediate threat to patients.", Statement stated.
"SAHPRA advises patients to consult their physician or pharmacist and to continue taking the drug until they have a replacement medicine, "said statement.
Recall affects local product Dynaval Co 80 / 12.5 mg, 160/12, 5 mg and 160/25 mg, which is provided by Pharma Dynamics
Pharma Dynamics CEO Erik Roos said the company was working closely with SAHPRA to ensure a quick recall of all affected products. South Africa
"The health and safety of patients is our main concern. Regular quality checks are being performed at the site level and once the impurity was detected earlier this month, international health authorities were immediately notified and recall protocols were followed, "said Roos
]. Patients can return the products to the pharmacy of origin.
SAHPRA clbadifies the recall into Clbad II as a Type B recall, which requires the pharmaceutical companies concerned to notify only health professionals, pharmacists and other authorized prescribers. remember because it does not pose a serious threat to life.
"Patients are advised to consult a health professional before stopping the use of valsartan," said Roos
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