China is hit regularly by quality-control scandals, fuelling fear over the safety of food and medicines and anger at regulatory lapses.
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.
According to China Business Journal, there were a total of 12,226 bottles in the batch, each bottle containing 50 milliliters of plasma, with an expiration date of June 8, 2021.
It asked medical institutions to halt the use of the batch and seal remaining supplies for further investigation.
Immunoglobulins are antibodies produced by white blood cells that are used to treat immune deficiencies caused by illnesses such as leukaemia, hepatitis and rabies. Just $5 a month.
The batch of intravenous immunoglobulin was produced by Shanghai Xinxing Pharmaceutical Co. The samples were from a batch of 12,000 plasma products manufactured by Shanghai-based China Meheco Xinxing Pharma Co., Ltd. A representative of Jiangxi Provincial Disease Control Centre said it had not yet discovered cases of patients having contracted HIV from the batch.
Intravenous immunoglobulin, a blood product, prepared from the serum of between 1,000 and 15,000 donors per batch is used for the treatment of low immunity that is triggered by conditions like blood cancer and hepatitis.
Public faith in China's health regulators has been shaken by previous scandals. "All the related production and inspection records have been sealed", Xinhua News Agency reported. Wu, one of four CFDA officials being investigated, was in charge of China's vaccine regulation at the time.
Recently, more than 100 children were administered expired polio vaccines.
The ABC approached the China Meheco Group and various government bodies for clarification but was not able to receive a response - most government offices and companies are now closed in China due to Lunar New Year public holiday.
The source of the contamination is suspected to be from an HIV-positive blood donation.
Shanghai Xinxing is the country's leading manufacturer of blood products.
'The detection of HIV antibodies ... could mean that the products have been contaminated by the blood of HIV-infected people, ' said Wang Yuedan, deputy director at the Peking University Health Science Center.
A study of 280,000 villagers in Henan who had sold their blood found that more than 36,000, about one in eight, had HIV or Aids.
The Associated Press contributed reporting to this story.