According to the test results from the Hanoi Center for Drug, Cosmetic and Food Testing, the drug sample was taken from Tri Viet Trading and Investment Consulting Co., Ltd. (coaster 221, Hapu Pharmaceutical and Medical Equipment Distribution Center, No. 1 Nguyen Huy Tuong, Thanh Xuan District, Hanoi) showing that the product did not meet the quality standards for Quality and In half-ness. The model is identified as batch No. 011024, production date 25.10.2024, valid until 24.10.2027, circulating registration number: 893115586524 (old certificate: VD-32740-19).
Previously, on May 20, 2025, Medipharco Pharmaceutical Joint Stock Company sent a document proposing a voluntary recall of the above drug lot after detecting that the drainage sample did not meet sensory targets.
According to current regulations, the Department of Drug Administration (Ministry of Health) requires:
National recall of the above Ofleye Drops ( Of Ofloxacin 0.3%) eye and ear drops.
Medipharco Pharmaceutical Joint Stock Company must:
Send a revocation notice to all wholesalers, retailers, and drug users within 2 days from the date of signing the document;
Revok all drug lots;
Submit a revocation report to the Drug Administration within 33 days, along with documents proving the revocation process as prescribed in Circular 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health.
Departments of Health of provinces, cities and sectors:
Notify and publish the revocation information on the unit's electronic information portal;
Inspect and supervise the implementation of the recall; strictly handle violations and report to the Department of Drug Administration.
The Department of Health of Thua Thien Hue province is responsible for inspecting and supervising Medipharco Medipharco Pharmaceutical Joint Stock Company in recovering and treating drugs in accordance with regulations.
The Drug Administration of Vietnam recommends that drug business and users proactively review and stop using the above-mentioned batch of substandard drugs to ensure the safety of patients.
