Suspension of circulation of Daeshin Protase film-coated tablets

The Drug Administration of Vietnam (Ministry of Health) has just sent a document to the Department of Health of 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 not meeting quality standards for Bromelain quantification.

Illustration photo.

The suspended Daeshin Protase drug has batch number: 5009, manufacturing date: September 9, 2015, expiry date: September 8, 2018, registration number: VN-13103-11, manufactured by Dae Hwa Pharmaceutical Co., Ltd. (Korea), imported by Vietnam Medical Import-Export Joint Stock Company.

The drug sample was taken by the Central Institute for Drug Control at 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, Thanh Xuan, Hanoi).

The drug is indicated for use in cases of edema and swelling due to trauma or surgery. The drug can also be used in combination to treat upper respiratory tract diseases such as pharyngitis, bronchitis, sinusitis, and pneumonia.

The Drug Administration of Vietnam requires Vietnam Medical Import-Export Joint Stock Company to coordinate with drug suppliers and distributors to send recall notices to wholesalers and retailers using Daeshin Protase film-coated tablets (Bromelain 40mg; Crystallized Trypsin 1mg) and recall the entire batch of drugs that do not meet the above quality standards.

The Drug Administration also requested the Department of Health of provinces and cities across the country, and health sectors to notify drug businesses and users to recall the above batch of substandard drugs, inspect and supervise units implementing the notification; and handle violators according to current regulations.

With the Hanoi Department of Health, the Drug Administration requested to inspect and supervise Vietnam Medical Import-Export Joint Stock Company to recall and handle recalled drugs according to regulations.

According to Vietnam+