Published: Wed, July 18, 2018
Medicine | By Brett Sutton

Prinston Pharmaceutical Issues Voluntary Recall Of Valsartan

Prinston Pharmaceutical Issues Voluntary Recall Of Valsartan

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.

In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they "do not meet our high quality standards".

Despite the possible danger to health, the FDA said that patients must continue with the medicine until they have a replacement as Valsartan is used to treat serious medical conditions and patients can not stop taking medication without another valid prescription. The medicines which were said to contain N-nitrosodimethyamine as it is suspected to contain human carcinogen. Instructions for returning recalled products and crediting are given in the recall letter. "That is why we've asked these companies to take immediate action to protect patients".

Users prescribed drugs with the presence of valsartan are encouraged to continue taking the recalled drug until they're able to speak with their doctor for alternative options. He said the importers of the Zhejiang Huahai-supplied valsartan included Karachi's Amarant Pharmaceuticals, Efroze Chemical Industries, High-Q Pharmaceuticals, Pharm-Evo, Safe Pharmaceuticals, Sami Pharmaceuticals and Tabros Pharma, and Lahore's Searle Pharmaceuticals and Genetics Pharmaceuticals. "EMA has made this aspect of the review a priority and will update the public as soon as new information becomes available", the agency said. In some patients, vulsartan is becoming life-saving medicine. The carcinogen was detected in an active pharmaceutical ingredient (API) manufactured by Zhejian Huahai Pharmaceutical.

Zhejiang Huahai, which was founded in 1989 and listed on the Shanghai stock exchange in 2003, was one of the first Chinese companies to get drugs approved in the US market.


This is the list of medications recalled by the FDA.

"When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market", said Commissioner Dr. Scott Gottlieb.

The Ministry of Health and Wellness will continue to follow warnings from the global regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public.

"It's not just valsartan", said Lever.

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