Recall of Ofleye Drops eye and ear drops

(Dan Tri) - The Drug Administration has just announced a nationwide recall of a batch of Ofleye Drops eye and ear drops (Ofloxacin 0.3%) due to level 3 violations.

A batch of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops has just been determined to not meet quality standards in terms of properties and clarity. The test results were announced by the Hanoi Center for Drug, Cosmetic and Food Testing on May 23.

The defective batch of medicine has registration number 893115586524 (old registration number: VD-32740-19), batch number 011024, manufactured on October 25, 2024 and has an expiration date of October 24, 2027. This product is manufactured by Medipharco Pharmaceutical Joint Stock Company.

A batch of Ofleye Drops eye and ear drops (Ofloxacin 0.3%) (Photo: CT).

Previously, on May 20, Medipharco Pharmaceutical Joint Stock Company proactively sent a document proposing a voluntary recall of this batch of drugs. The reason given was that the company discovered that the sample of the product batch did not meet sensory standards.

The Drug Administration of Vietnam ( Ministry of Health ) has determined this to be a level 3 violation. Therefore, the Drug Administration of Vietnam has issued a nationwide recall notice for this batch of Ofleye Drops (Ofloxacin 0.3%) eye and ear drops.

The Department requested Medipharco Pharmaceutical Joint Stock Company to coordinate with distributors to notify the recall to all wholesale, retail and user establishments. The entire batch of substandard drugs must be completely recalled.

Medipharco is responsible for sending a recall report to the Drug Administration within 33 days from June 4. The report must detail the quantity produced, distributed, date of manufacture, quantity recalled, and evidence of recall implementation at the facilities that purchased the drug.

The Department of Health of provinces and cities is required to widely notify drug businesses and users about the recall of this batch of drugs. At the same time, the Departments must inspect and supervise the recall, strictly handle violators and report to the Drug Administration and relevant agencies.

Hue City Department of Health is responsible for inspecting and supervising Medipharco Pharmaceutical Joint Stock Company in the process of recalling and handling the recalled drug batch in accordance with regulations.

Source: https://dantri.com.vn/suc-khoe/thu-hoi-lo-thuoc-nho-mat-tai-ofleye-drops-20250605142550387.htm