The 29 lots of single and 51 lots of combination Valsartan medicines distributed under the Actavis label in the USA are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical.
The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications.
Patients and prescribers have been calling DRAP whether valsartan medicine manufactured by Pakistani companies produces cancer or are banned or should they stop taking medicine. The carcinogen was detected in an active pharmaceutical ingredient (API) manufactured by Zhejian Huahai Pharmaceutical.
The FDA said not all products containing valsartan were being recalled in the United States.
FDA has asked the patients not to take any medicine manufactured by this company and do not buy any product in which there is no name of the manufacturer. However, not all products containing valsartan are being recalled.
The FDA advises concerned patients to check the drug name and company name on the label of their prescription bottle or contact the pharmacy that dispensed the medicine for verification. The FDA also said patients should talk to their pharmacists and doctors who prescribed the medicine to discuss their next steps.
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The Ministry of Health is assuring the public that Valsartan products in Barbados have not been affected by an worldwide recall. Zhejiang Huahai Pharmaceuticals supplied the three USA -based pharmaceutical companies with these products, according to The New York Times.
The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied valsartan on July 5, said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA. Vulsartan is the commonly used medication used to treat high blood pressure and heart failure. The distribution firm is notifying distributors and other customers by recall letter and arranging for return of all recalled products.
Heath experts warn patients using valsartan to check their bottle to identify its manufacturer.
The FDA said it would continue to investigate the matter and also assess the effects on patients while establishing measures to reduce the impure component in future batches.
This is the list of medications recalled by the FDA.