Pharmedic fined over substandard sodium chloride 0.9% eye drops

Pharmedic Pharmaceutical Joint Stock Company has been fined 50 million VND by the Drug Administration of Vietnam for manufacturing a batch of 0.9% sodium chloride eye drops that failed quality standards.

The Drug Administration of Vietnam recently issued a decision to fine Pharmedic Pharmaceutical Joint Stock Company 50 million VND. This penalty comes after a quality violation, which occurred in May, involving a batch of 0.9% sodium chloride eye drops. In addition to the fine, Pharmedic is required to cover the costs of recalling, disposing of the substandard medication, and compensating for any damages as stipulated by regulations. Health authorities in Quang Ngai and Ho Chi Minh City have assessed the risks posed by the non-compliant batch to user health.

The problematic batch of eye drops, identified with circulation registration number 893100060724 and batch number 10370725, was manufactured on 14/7/2025 and has an expiration date of 14/1/2028. This product is a common saline solution used for both eyes and nose, widely available in pharmacies across the country.

At the time of the discovery, the Drug Administration of Vietnam (Ministry of Health) ordered the recall of the 0.9% sodium chloride eye drop batch due to a "level 3 quality violation." Specifically, random samples collected from the market by the Quang Ngai Province Drug, Cosmetics, and Food Testing Center and the Ho Chi Minh City Drug Testing Institute revealed that the solution was not transparent. It contained sediment, suspended particles, or impurities visible to the naked eye.

Health agencies classified this as a low-risk violation, not directly life-threatening or causing immediate severe consequences. However, given the sensitivity of the eyes, using an impure solution can easily cause irritation, damage, or reduce treatment effectiveness. Consequently, the Drug Administration of Vietnam mandated a full recall of the entire batch.