Ministry of Health: Recalling the entire batch of Ofleye Drops eye and ear drops due to violations

On June 5, the Drug Administration of Vietnam ( Ministry of Health ) informed that it had just sent a document to the Department of Health of provinces and centrally-run cities; Medipharco Pharmaceutical Joint Stock Company (No. 8 Nguyen Truong To Street, Phuoc Vinh Ward, Hue City, Thua Thien Hue Province, now Hue City) regarding the notice of recalling level 3 violating drugs.

According to the Drug Administration, based on the results of testing drugs, cosmetics, and food, Hanoi city sent a test certificate for the eye and ear drops solution Ofleye Drops (Ofloxacin 0.3%), GĐKLH number: 893115586524 (old registration number: VD-32740-19), batch number: 011024; production date: October 25, 2024; expiration date: October 24, 2027, manufactured by Medipharco Pharmaceutical Joint Stock Company.

The drug sample was taken by the Hanoi City Drug, Cosmetic and Food Testing Center at Tri Viet Investment Consulting and Trading Company Limited (Counter 221, Hapu Pharmaceutical and Medical Equipment Distribution Center, Building 24T1, No. 1 Nguyen Huy Tuong, Thanh Xuan, Hanoi).

The above batch of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops was determined to be a level 3 violation, so the Drug Administration announced a nationwide recall.

The Drug Administration of Vietnam also announced that it had received an official dispatch from Medipharco Pharmaceutical Joint Stock Company requesting a voluntary recall of the above-mentioned eye and ear drops solution product Ofleye Drops (Ofloxacin 0.3%) due to failure to meet sensory standards.

The Ministry of Health requires Medipharco Pharmaceutical Joint Stock Company to coordinate with drug distributors to send recall notices to wholesalers and retailers using the above-mentioned Ofleye Drops (Ofloxacin 0.3%) eye and ear drops and recall the entire batch of drugs that do not meet quality standards.

At the same time, the manufacturing unit must send a recall report to the Department of Drug Administration within 33 days from June 4. The recall dossier includes the quantity produced, the quantity distributed, the date of manufacture, the quantity recalled, and evidence of the recall at wholesale, retail, and user establishments that purchased the drug according to the provisions of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health regulating the quality of drugs and pharmaceutical ingredients.

For the Department of Health of provinces and centrally-run cities, and health sectors, the Ministry of Health requires notifying drug businesses and users to recall the above-mentioned substandard drug batches, publishing information about the drug recall decision on the Department's website, inspecting and supervising units implementing this notice; handling violators according to current regulations; reporting to the Drug Administration of Vietnam and relevant authorities.

Hue City Department of Health inspects and supervises Medipharco Pharmaceutical Joint Stock Company to recall and handle recalled drugs according to regulations./.

(Vietnam+)

Source: https://www.vietnamplus.vn/bo-y-te-thu-hoi-toan-bo-lo-thuoc-nho-mat-tai-ofleye-drops-do-vi-pham-post1042515.vnp