Anti-inflammatory drug Alfachim 4.2 recalled nationwide

The Drug Administration of Vietnam (Ministry of Health) has announced a nationwide recall of the anti-inflammatory and anti-edema drug Alfachim 4.2 manufactured by Cuu Long Pharmaceutical Joint Stock Company.

Mr. Ta Manh Hung, Deputy Director of the Department of Drug Administration ( Ministry of Health ) has just signed an official dispatch to recall nationwide the drug batch Alfachim 4.2 (Chymotrypsin (equivalent to 21 microkatal chymotrypsin) 4200 IU), circulation registration license number VD-34573-20, batch number 03010624, manufactured on June 1, 2024 and expiry date June 1, 2026, manufactured by Cuu Long Pharmaceutical Joint Stock Company.

The reason for the recall is that the above drug sample does not meet the quality standards for quantitative indicators (level 2 violation).

Alfachim 4.2 is used to treat edema after trauma, surgery, and burns.

According to the Drug Administration of Vietnam, the Department previously issued an official dispatch to recall this batch of Alfachim 4.2 in Hanoi and requested Cuu Long Pharmaceutical Joint Stock Company to coordinate with the quality control agency and the State drug testing agency to collect 2 additional samples and send the collected samples to the Central Drug Testing Institute or the Ho Chi Minh City Drug Testing Institute to test the quality of quantitative indicators.

However, up to now, after 15 days from May 20, Cuu Long Pharmaceutical Joint Stock Company has not reported to the Drug Administration the results of the quality inspection of the 2 additional samples, only reporting on the production, distribution of the drug and the recall report for the above batch of Alfachim 4.2 tablets. Cuu Long Pharmaceutical Joint Stock Company has requested a voluntary recall of Alfachim 4.2 tablets with the above batch number.

Therefore, the Drug Administration Department issued a notice to recall this batch of medicine nationwide, requiring Cuu Long Pharmaceutical Joint Stock Company to coordinate with the drug distributor within 2 days to send a recall notice to the wholesale and retail establishments using Alfachim 4.2 medicine and to recall the entire batch of medicine that does not meet the above quality standards.

Send the recall report to the Drug Administration within 18 days from the date of signing the official dispatch, the recall dossier includes the production quantity, distribution quantity, production date, recalled quantity, evidence of recall implementation at wholesale, retail and user establishments that purchased the drug according to regulations.

The Department of Health of provinces and centrally-run cities and the Department of Health of all sectors shall notify drug trading and using establishments to recall the above batch of substandard drugs, publish information about the decision to recall drugs on the Department's website, and inspect and supervise the implementing units.

The Hanoi Department of Health and the Vinh Long Department of Health inspect and supervise Cuu Long Pharmaceutical Joint Stock Company in recalling and handling recalled drugs according to regulations; at the same time, evaluate the effectiveness of the drug recall (whether the recall is thorough, whether the product is still likely to continue to be circulated, used, and has the risk of adversely affecting the health of users).

cand.com.vn

Source: https://baolaocai.vn/thu-hoi-thuoc-khang-viem-alfachim-42-tren-toan-quoc-post403676.html