Suspend circulation and recall of SOS Fever® Fort soft capsules due to quality violations
The Hanoi Department of Health has just issued a document suspending the circulation and recalling SOS Fever® Fort soft capsules due to quality violations.
The Hanoi Department of Health has just issued a directive to the heads of medical facilities in the area, the district, town and city health departments, Ampharco USA Pharmaceutical Joint Stock Company, Dadison USA Joint Stock Company located at counter 431, 4th floor, Hapu Medicenter, No. 1 Nguyen Huy Tuong, Thanh Xuan regarding the recall of SOS Fever® Fort medicine that does not meet quality standards.
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Accordingly, the Hanoi Department of Health announced the recall in Hanoi and the establishments that purchased the batch of medicine provided by Dadison USA Joint Stock Company: SOS Fever® Fort soft capsules (Ibuprofen 400mg), Registration number: VN-26102-17, Batch number: B4001, Manufacturing date: February 22, 2024, Expiry date: February 22, 2027, manufactured by Ampharco USA Pharmaceutical Joint Stock Company, not meeting the quality requirements for properties (level 3 violation).
In addition, the Department also requested Ampharco USA Pharmaceutical Joint Stock Company and Dadison USA Joint Stock Company to completely recall the above-mentioned violating SOS Fever® Fort soft capsule and send the recall report and recall records to the Department of Drug Administration, Hanoi Department of Health according to regulations.
Medical facilities, drug wholesalers and retailers in the area must urgently review and recall the batches of drugs that do not meet the above quality standards. The Health Departments of districts, towns and cities shall notify the medical facilities in the area under their management; conduct inspections and supervise the recall implementation of the facilities (if any).
Hanoi Department of Health will inspect and supervise the recall of units, notify units to know, implement and report the implementation to the Department of Health.
A few days earlier, the Hanoi Department of Health also issued a document recalling the drug Alphatrypa DT that did not meet quality standards. The drug was supplied by Nhat Thanh Pharma International Company Limited; the place of production and distribution was Central Pharmaceutical Joint Stock Company I-Pharbaco because it did not meet quality standards for quantitative indicators (level 2 violation).
The Department of Health requests Central Pharmaceutical Joint Stock Company I - Pharbaco and Nhat Thanh Pharma International Company Limited to thoroughly recall: Alphatrypa DT tablets (Chymotrypsin 4.2mg); Phone number: VN-26281-17; Batch number: 84324; Production date: May 25, 2024; Expiry date: May 25, 2026; send a recall report and recall documents according to regulations in Official Dispatch 3288/QLD-CL.
At the same time, medical facilities, drug wholesalers and retailers in the area urgently review and recall the batches of drugs that do not meet the above quality standards. The Health Departments of districts, towns and cities notify the medical facilities in the area under their management; conduct inspections and supervise the recall implementation of the facilities (if any).
It is known that recently, a series of drugs violating quality have been recalled. Specifically, in mid-September 2024, the Hanoi Department of Health announced the recall of Zovitit Microparticle Capsules (Acyclovir 200mg), GĐKLH number: VN-15819-12, Batch number: 0017, NSX: 03/05/23, EXP: 02/05/26 manufactured by SC Slavia Pharma SRL (Romania), imported by Codupha Central Pharmaceutical Joint Stock Company.
Accordingly, the Codupha Hanoi Branch of Central Pharmaceutical Joint Stock Company coordinated with Codupha Central Pharmaceutical Joint Stock Company to recall the batch of drugs that did not meet quality standards that had been distributed, prepare a recall file, and report the recall to the Hanoi Department of Health (if any).
In addition to the above mentioned medicine, the Hanoi Department of Health announced the recall of Cetecocenzitax tablets (Cinarizin 25mg), GĐKLH number: VD-20384-13; Batch number: 01/0823; NSX: 030823; HD: 030826, violating level 3, produced by Central Pharmaceutical Joint Stock Company 3.
The Hanoi Department of Health requests public health facilities under the sector, non-public health facilities, drug trading enterprises, and drug retail establishments in the area to review and thoroughly recall the above batch of drugs; send recall reports and recall records to the Department of Health and the Department of Drug Administration according to regulations. The Department of Health will inspect and supervise the recall of units and establishments.
The Health Department of districts, towns and cities shall notify the medical establishments under their management; conduct inspections and supervise the implementation of the recall by the establishments (if any).
Note, coordinate with media agencies to inform drug businesses and users and people not to trade or use.
The Drug Administration of Vietnam (Ministry of Health) also issued an official dispatch announcing the recall of Ubiheal 300 tablets (Thioctic acid 300 mg) of Nam Ha Pharmaceutical Joint Stock Company due to failure to meet quality standards.
The Drug Administration of Vietnam requests the Department of Health of provinces and centrally-run cities and the Health Departments of all sectors to notify drug trading and using establishments to recall the above batch of Ubiheal 300 Tablets (Thioctic acid 300 mg) that do not meet the above quality standards.
In addition, publish information about the decision to recall drugs on the Department's website, inspect and supervise units implementing this notice; handle violators according to current regulations; report to the Drug Administration and relevant authorities.
At the same time, the Drug Administration of Vietnam (Ministry of Health) assigned the Hanoi Department of Health and the Nam Dinh Provincial Department of Health to inspect and supervise Nam Ha Pharmaceutical Joint Stock Company to recall and handle recalled drugs according to regulations.
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