On July 18, the Ministry of Health informed that the Drug Administration of Vietnam requested Me Di Sun Pharmaceutical Joint Stock Company to coordinate with drug distributors to recall all Femancia drugs for treating anemia.
Specifically, the Drug Administration of Vietnam has just issued a document announcing the mandatory recall of all drug batches for the drug Femancia; registration number: VD-27929-17; dosage form: hard capsule; Active ingredient, concentration/content: Elemental iron (in the form of Ferrous fumarate 305 mg) 100 mg; Folic Acid 350mcg, manufactured by Me Di Sun Pharmaceutical Joint Stock Company, address: 521 An Loi Quarter, Hoa Loi Ward, Ho Chi Minh City (old address: 521 An Loi Quarter, Hoa Loi Ward, Ben Cat Town, old Binh Duong Province) at all pharmaceutical businesses, medical examination and treatment facilities and users (drugs violating level 2).
The above batch of drugs is recalled according to the provisions of Point b, Clause 1, Article 62 of the Law on Pharmacy (The drug circulation registration certificate is revoked in the cases specified in Points a, b, d, dd and e, Clause 1, Article 58 of the Law on Pharmacy 2016).
The Drug Administration of Vietnam requested Me Di Sun Pharmaceutical Joint Stock Company to coordinate with the drug distributor to recall all of the above Femancia drugs within 15 days, starting from July 16.
Drug trading and using establishments, medical examination and treatment establishments shall not trade, supply, dispense, use Femancia and reserve the remaining drugs at the establishment, and shall return the drugs to the supplying establishments according to regulations.
Ho Chi Minh City Department of Health inspects and supervises Me Di Sun Pharmaceutical Joint Stock Company to recall and handle the above-mentioned recalled Femancia drug according to regulations; at the same time, evaluate the effectiveness of the drug recall (is the recall thorough, is the product still likely to continue to be circulated, used and has the risk of adversely affecting the health of users or not).
The Department of Health of provinces and centrally-run cities and health sectors shall notify drug businesses and users to recall the above-mentioned Femancia drug, publish information about the drug recall decision on the Department's website, inspect and supervise units implementing this notice; handle violators according to current regulations; report to the Drug Administration of Vietnam and relevant authorities.
The Drug Administration also requires the company to report to the Drug Administration and the Ho Chi Minh City Department of Health within 3 days of completing the drug recall; the reporting documents must comply with regulations.
In addition to withdrawing the drug's registration certificate from the list of drugs granted a registration certificate for circulation in Vietnam, the Drug Administration of Vietnam said that the drug Femanica will not be produced and circulated on the market from July 16, 2025./.
Source: https://www.vietnamplus.vn/bo-y-te-cam-san-xuat-luu-hanh-loai-thuoc-femancia-dieu-tri-thieu-mau-post1050322.vnp
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