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China investigating 'HIV positive' human immunoglobulin case

(Xinhua)

Updated: 2019-02-07

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A screenshot on its official website shows the human immunoglobulin for intravenous injection manufactured by China Meheco Xinxing Pharma Co in Shanghai.

BEIJING/SHANGHAI - China's health authorities Wednesday launched an investigation into a batch of human immunoglobulin for intravenous injection, which were reported to be HIV antibody positive.

The drugs, carrying the batch number of 20180610Z, were manufactured by China Meheco Xinxing Pharma Co in Shanghai.

Shanghai's drug watchdog has ordered the company to halt production and initiate emergency recall of its products.

The National Health Commission said it has informed the National Medical Products Administration to demand medical institutions nationwide to stop using and seal products of the said batch number.

The commission said the risk of HIV infection is "very low" for those who have been injected the product, based on related literatures, manufacturing technique and the pH value of the product.

A follow-up monitoring plan has been made for these people, it said.

The commission has sent a working team to Shanghai to supervise and guide related work.

A group of experts sent by the National Medical Products Administration has arrived in Shanghai for site inspection at the company. All the related production and inspection records have been sealed.


Tests show Meheco's human immunoglobulin HIV negative

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A photo of China Meheco Xinxing Pharma Co in Shanghai on its official website.

BEIJING - Tests showed the reportedly HIV-positive human immunoglobulin for intravenous injection were virus negative, China's drug watchdog said Thursday.

The results of the nucleic acid test (NAT) on HIV, HBV and HCV for medical products manufactured by Shanghai-based China Meheco Xinxing Pharma Co., Ltd. were all negative, the National Medical Products Administration (NMPA) said in a statement.

The NAT result on HIV for patients in Jiangxi was also negative, the statement said.

National Health Commission on Tuesday informed the NMPA that a batch of Meheco-produced human immunoglobulin, carrying the batch number of 20180610Z, were found HIV antibody positive.

The NMPA sent work teams to Shanghai and Jiangxi and demanded its Shanghai bureau launch immediate site inspections and conduct drug tests on the medical products.

The related products have been sealed, and medical institutions nationwide have been asked to stop using them.

Further investigations are underway.


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Link: China's Central Government / World Health Organization / United Nations Population Fund / UNICEF in China

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