The circulation of Daeshin Protase film-coated tablets has been suspended.

The Drug Administration Department (Ministry of Health) has just sent a document to the Departments of Health in all provinces and cities nationwide announcing the decision to suspend the nationwide circulation of Daeshin Protase film-coated tablets (Bromelain 40mg; Crystallized Trypsin 1mg).

The drug was suspended from circulation and recalled due to failing to meet quality standards regarding the quantitative analysis of Bromelain.

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The suspended Daeshin Protase drug has batch number: 5009, manufacturing date: 09/09/2015, expiry date: 08/09/2018, registration number: VN-13103-11, manufactured by Dae Hwa Pharmaceutical Co., Ltd. (Korea), and imported by Vietnam Medical Import-Export Joint Stock Company.

The drug samples were collected by the Central Institute for Drug Testing from Lang Son Pharmaceutical and Medical Supplies Trading Joint Stock Company (Counter 216, 2nd floor, Hapu Medicenter Pharmaceutical and Medical Equipment Distribution Center, No. 1 Nguyen Huy Tuong Street, Thanh Xuan District, Hanoi).

The medication is indicated for use in cases of edema and swelling due to injury or surgery. It may also be used in combination therapy for upper respiratory tract infections such as pharyngitis, bronchitis, sinusitis, and pneumonia.

The Drug Administration of Vietnam requires the Vietnam Medical Import-Export Joint Stock Company to coordinate with the drug supplier and distributor to send recall notices to wholesale, retail, and end-user establishments of Daeshin Protase film-coated tablets (Bromelain 40mg; Crystallized Trypsin 1mg) and to proceed with the recall of the entire batch of the aforementioned substandard drug.

The Drug Administration also requested the Departments of Health in provinces and cities nationwide, and the health departments of various sectors, to notify businesses and users of the recalled batch of substandard drugs mentioned above, to inspect and monitor the units implementing the notification, and to handle units that violate the regulations according to current laws.

The Hanoi City Department of Health and the Drug Administration of Vietnam have requested the inspection and supervision of Vietnam Medical Import-Export Joint Stock Company in carrying out the recall and handling of recalled drugs in accordance with regulations.

According to Vietnam+