The DAV announced the recall on 17/7. The affected drug is Femancia, registration number VD-27929-17, registered under MediSun Pharmaceutical Joint Stock Company, located in Hoa Loi Ward, Ho Chi Minh City (formerly Hoa Loi Ward, Ben Cat Town, Binh Duong Province).
Femancia has been withdrawn from the Vietnamese market because two batches violated quality standards within 60 months. Under Vietnamese pharmaceutical law, a drug's registration is revoked if at least two batches are recalled for level 2 violations within 5 years of licensing.
Drug quality violations are classified into three levels. A level 2 violation means the drug does not meet quality standards in a non-critical parameter, not directly posing a serious threat to users' health or life. However, it can impact treatment efficacy or create safety risks with prolonged use or high doses. Common level 2 violations relate to solubility, dosage, or stability.
Consequently, Femancia will no longer be produced or sold in Vietnam. MediSun Pharmaceutical Joint Stock Company is responsible for recalling all existing stock according to regulations.
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Femancia drug label. Screenshot |
Femancia drug label. Screenshot
In March, the DAV announced the recall of two batches of Femancia hard capsules (Elemental iron (as ferrous fumarate 305 mg) 100 mg; Folic acid 350 mcg), registration number VD-27929-17. These batches failed to meet quality standards for dosage and solubility, constituting level 2 violations.
Drug information centers describe Femancia as an iron supplement to prevent iron deficiency and anemia.
Le Nga
