Pharmedic fined for substandard eye drop production

The Drug Administration of Vietnam, under the Ministry of Health, has fined Pharmedic Pharmaceutical Medicinal Materials Joint Stock Company 50 million VND for producing a substandard batch of 0.9% sodium chloride eye drops.

The affected batch (registration number 893100060724, lot number 10370725) was manufactured on July 14, 2025, with an expiration date of January 14, 2028. Testing revealed the product failed to meet clarity standards, which is a sensory quality requirement for eye drops.

The violation is classified as level 3, meaning the quality defect does not impact the treatment effectiveness or safety of the product but fails to meet specific regulatory requirements. In addition to the fine, Pharmedic is responsible for all costs related to the recall and disposal of the batch, as well as any required compensation for damages. The Drug Administration has also requested health departments in Quang Ngai and Ho Chi Minh City to assess potential risks to users.