Recall of poor quality Ofleye Drops eye and ear drops

On June 5, the Drug Administration of Vietnam (Ministry of Health) issued an official dispatch requesting a nationwide recall of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops produced by Medipharco Pharmaceutical Joint Stock Company (in Hue City, Thua Thien Hue Province) for not meeting quality standards.

Previously, the Drug Administration Department received an official dispatch from Medipharco Pharmaceutical Joint Stock Company requesting a voluntary recall of the eye and ear drops solution product Ofleye Drops (Ofloxacin 0.3%), registration number: 893115586524 (old registration number: VD-32740-19), batch number: 011024; manufacturing date: October 25, 2024; expiry date: October 24, 2027 due to the finding that a sample of a batch of the eye and ear drops solution product Ofleye Drops (Ofloxacin 0.3%) mentioned above did not meet sensory standards.

Request for nationwide recall of Ofleye Drops eye and ear drops

Then, on May 23, the Hanoi Center for Drug, Cosmetic and Food Testing sent a test report on the eye and ear drops solution Ofleye Drops (Ofloxacin 0.3%), GĐKLH number: 893115586524 (old registration number: VD-32740-19), batch number: 011024; manufacturing date: October 25, 2024; expiry date: October 24, 2027, manufactured by Medipharco Pharmaceutical Joint Stock Company. The test results showed that the drug sample did not meet quality standards in terms of properties and clarity.

Notably, the drug sample was taken by the Hanoi Center for Drug, Cosmetic and Food Testing at Tri Viet Investment Consulting and Trading Company Limited (at counter 221, Hapu Pharmaceutical and Medical Equipment Distribution Center, at building 24T1, No. 1 Nguyen Huy Tuong, Thanh Xuan, Hanoi) - this is also the largest pharmaceutical business center in the North.

With the above test results, the above batch of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops is determined to be a level 3 violation. Therefore, the Drug Administration of Vietnam announces a nationwide recall of the above batch of solutions, and requests Medipharco Pharmaceutical Joint Stock Company to coordinate with drug distributors within 2 days from the date of signing this document, send a recall notice to wholesalers, retailers, and users of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops and recall the entire batch of drugs that do not meet the above quality standards; send a recall report to the Drug Administration of Vietnam.

The Drug Administration also requested the Department of Health of provinces and cities, and health sectors to notify drug businesses and users to recall the above batch of substandard drugs, publish information about the drug recall decision on the Department's website, inspect and supervise units implementing this notice; and handle violators according to current regulations.

NGUYEN QUOC

Source: https://www.sggp.org.vn/thu-hoi-thuoc-nho-mat-tai-ofleye-drops-kem-chat-luong-post798235.html