The Drug Administration of Vietnam (Ministry of Health) has just issued a decision to recall nationwide a batch of Colchicina Seid tablets (Colchicine 1mg), registration certificate number VN-22254-19, batch number V008, manufactured by Seid Company, S.A. (Spain) and imported by Nhat Anh Pharmaceutical Co., Ltd.
According to the decision, the recalled batch of drugs has a production date of May 20, 2024, and a shelf life of May 20, 2029.
Previously, the Central Institute for Drug Quality Control had Official Dispatch No. 822/VKNTTW-KHTH with Test Sheet No. 56L420, reporting the test results of the Colchicina Seid drug sample belonging to batch V008.
The drug sample was taken by the Central Institute for Drug Quality Control at Quynh Lan Pharmaceutical Co., Ltd., Stand 328, 3rd floor, Hapu Medicenter, No. 1 Nguyen Huy Tuong, Thanh Xuan, Hanoi.
Test results showed that the drug sample did not meet quality standards in terms of indicators: properties, solubility, consistency of content and Quantity. Violation was determined at level 2.
After that, the Central Institute for Drug Quality Control continued to take additional samples for this drug batch itself. According to Official Dispatch No. 1242/VKNTTW-KHTH, Test Sheets No. 56Gt52, 56Gt53 and 56Gt54 showed that the V008 drug batch continued to fail to meet quality standards for dissolution index.
Based on the test results, the Drug Administration of Vietnam decided to recall the entire nationwide batch of Colchicina Seid drug batch number V008.
The Drug Administration of Vietnam requests Nhat Anh Pharmaceutical Co., Ltd. to immediately stop trading and store all drugs in the recalled batch that still exist at establishments.
The enterprise is responsible for reporting the distribution situation of the drug batch to wholesale establishments and medical examination and treatment facilities to the Drug Administration of Vietnam and the Hanoi Department of Health within 7 days from the date the decision is issued.
At the same time, Nhat Anh Pharmaceutical Co., Ltd. must preside over and coordinate with relevant organizations and individuals to notify the recall to all wholesale and retail establishments, chain pharmacies, medical examination and treatment facilities and users who have received the above-mentioned batch of drugs.
The organization of the recovery and receipt of the entire batch of violating drugs must be completed within 15 days from the date the decision is issued.
The enterprise must also be responsible for handling the recalled drug shipment, paying expenses related to drug recall and handling, and compensating for damages according to the provisions of law.
After completing the recall, the company must send a written report on the recall results to the Drug Administration of Vietnam, Hanoi Department of Health and Ho Chi Minh City Department of Health within 3 days.
The Drug Administration of Vietnam requests wholesale and retail establishments and chain pharmacies to stop trading, supplying, and distributing the recalled batch of Colchicina Seid drugs; and at the same time notify and organize the recall and receipt of all distributed drugs to return to the supplying establishment.
For medical examination and treatment facilities, request to stop prescribing, selling and dispensing the recalled batch of drugs.
Drug users are also required to stop using the V008 batch and return the drug to the facility that provided it.
The Hanoi Department of Health and the Ho Chi Minh City Department of Health are responsible for inspecting and supervising Nhat Anh Pharmaceutical Co., Ltd. in implementing the recall and treatment of drugs according to regulations.
Departments of Health of provinces and centrally-run cities and health sectors are required to notify recall information to drug businesses and users; announce recall decisions on the unit's electronic information page, and at the same time inspect, supervise the implementation and handle violations.
