Urgent suspension of use of batch of medical biological products suspected of being infected with mad cow disease

The Drug Administration of Vietnam has just announced the temporary suspension of the purchase, sale and use nationwide of the batch of Human Albumin 20% medical biological product suspected of being contaminated with Creutzfeld-Jakob disease (mad cow disease).

Illustration: Internet

Accordingly, in an official dispatch sent to the Department of Health of provinces, hospitals under the Ministry of Health, and drug import and distribution companies, the Department of Drug Administration - Ministry of Health said it would temporarily stop buying, selling and using nationwide the batch of Human Albumin 20% medical biological product due to suspected contamination with Creutzfeld-Jakob disease (mad cow disease).

The official dispatch of the Drug Administration of Vietnam stated that, based on the announcement of the Economic and Commercial Committee of the Delegation of the European Union to Vietnam, along with the urgent warning of the Italian Drug Administration and the Hungarian National Institute of Nutrition and Medicine regarding the batch of medical biological products derived from blood and plasma produced by Kedrion SpA and Human BioPlazma Kft., there is a suspicion of possible Creutzfeld-Jakob disease contamination. Currently, the Creutzfeld-Jakob disease contamination as well as the strain causing Creutzfeld-Jakob disease have not been confirmed.

The Drug Administration also said that according to the report of Binh Viet Duc Company Limited (headquartered at 62/36 Truong Cong Dinh, Ward 14, Tan Binh District, Ho Chi Minh City), the above batch of biological products has been imported into Vietnam. Specifically, the product is called Human Albumin 20% (200g/l), 50ml bottle distributed by Central Pharmaceutical Joint Stock Company CPC1, batch numbers: 29610616, 29700916, 29590616.

To ensure safety for users, while waiting for the Drug Administration to coordinate with the Hungarian National Institute of Nutrition and Pharmacy to inspect and evaluate the safety of the product Human Albumin 20%, 200g/l, the Drug Administration requests the Department of Health, Hospitals and pharmaceutical businesses to temporarily stop buying, selling and using the above batch of biological products.

The Department of Health of localities urgently informs medical examination and treatment facilities and business units in the area to temporarily stop buying, selling and using the above batches of Human Albumin 20% (200g/l). At the same time, medical examination and treatment facilities should strengthen monitoring and handling of adverse reactions to the above drugs, if any, and report to the National Center for Drug Information and Adverse Drug Reaction Monitoring (13-15 Le Thanh Tong, Hoan Kiem, Hanoi) or the Regional Center for Drug Information and Adverse Drug Reaction Monitoring in Ho Chi Minh City (201B Nguyen Chi Thanh, District 5, Ho Chi Minh City).

The Drug Administration also requires import and distribution companies to temporarily stop importing, buying, selling, and distributing batches of Human Albumin 20% (200g/l) and to preserve them in accordance with the storage conditions stated on the product label; At the same time, notify business and treatment establishments to temporarily stop buying, selling, using, and preserving the product in accordance with the storage conditions stated on the label in case it has been distributed out of the company's warehouse.

In addition, the above companies must summarize the quantity of products in stock and report to the Department of Drug Administration before September 20, 2017.

Binh Viet Duc Company Limited in coordination with the manufacturer - Human BioPlazma Manufacturing and Trading Limited Liability Company, Hungary continues to monitor, update and report on the circulation situation in the home country of the above-mentioned Human Albumin 20% biological product and provide information related to the handling of this product by the local Management Agency.

According to TPO