Recall of batch of eye and ear drops due to failure to meet quality standards

According to the Drug Administration of Vietnam, Ministry of Health , this unit has just issued an official dispatch requesting a nationwide recall of the batch of eye and ear drops Ofleye Drops (Ofloxacin 0.3%), Registration Number: 893115586524 (Old Registration Number: VD-32740-19), Batch Number: 011024; Production Date: October 25, 2024; Expiry Date: October 24, 2027, manufactured by Medipharco Pharmaceutical Joint Stock Company.

Previously, the Hanoi Center for Drug, Cosmetic and Food Testing took drug samples from Tri Viet Investment Consulting and Trading Company Limited (counter 221, Hapu Pharmaceutical and Medical Equipment Distribution Center, Nguyen Huy Tuong, Thanh Xuan, Hanoi). The drug samples did not meet quality standards in terms of properties and clarity.

On May 22, the Drug Administration Department received a document from Medipharco Pharmaceutical Joint Stock Company requesting a voluntary recall of the above product batch due to the finding that a sample did not meet sensory standards.

"Thus, the above batch of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops is determined to be a level 3 violation," said the Drug Administration of Vietnam.

The Drug Administration of Vietnam 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, send a recall report to the Department of Drug Administration within 33 days from June 4, 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 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, the Drug Administration of Vietnam requests that these units notify drug trading and using establishments to recall the above-mentioned substandard drug batches, 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.

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

Ngoc Nga

Source: https://baophapluat.vn/thu-hoi-lo-thuoc-nho-mat-tai-vi-khong-dat-tieu-chuan-chat-luong-post550859.html