Recently, the Drug Administration of Vietnam ( Ministry of Health ) issued a decision to recall nationwide a batch of 0.9% sodium chloride eye drops, registration number: 893100060724, batch number: 10370725, manufacturing date: July 14, 2025, expiry date: January 14, 2028, manufactured by Pharmedic Pharmaceutical and Medicinal Materials Joint Stock Company.
According to the Ho Chi Minh City Institute of Drug Testing, this batch of medicine failed to meet quality standards regarding clarity (violation level 3).
Due to this violation, the Drug Administration of Vietnam requires Pharmedic Pharmaceutical and Medicinal Materials Joint Stock Company to cease business operations and quarantine the remaining recalled batch of drugs at its facility; and to report on the distribution of the drugs to wholesalers and medical examination and treatment facilities.
Simultaneously, the agency shall preside over and coordinate with relevant organizations and individuals to send recall notices for the drug batch to all wholesale and retail establishments, pharmacy chain organizations, and medical examination and treatment facilities that received the aforementioned drug batch; organize the recall and receipt of the entire drug batch, completing the process within 30 days.
In addition, businesses must handle the recalled batch of drugs; pay the costs of recalling and disposing of the recalled drugs; and compensate for damages as prescribed by law…
For wholesale and retail establishments, and chain pharmacy businesses, they must cease trading, supplying, and distributing the recalled batch of medicine mentioned above, notify and organize the recall and receipt of the entire batch of medicine, and return the medicine to the establishment that supplied it.
Healthcare facilities and users of the recalled drugs must cease prescribing, selling, dispensing, and using the drugs mentioned above, and return the drugs to the supplier.
Regarding the reasons why eye drops fail to meet quality standards for clarity, a pharmacist suggested that there are many causes, including the possibility of bottles colliding or rubbing against each other during sampling. Other possible causes include bacterial contamination and impurities in the medication.
According to experts, the Vietnamese Ministry of Health has very strict quality standards for ophthalmic pharmaceuticals (such as eye drops and eye ointments) to ensure absolute safety for the eyes. The main technical specifications that must be met include sterility, transparency, particle size, isotonicity, pH, volume limits, preservatives, containers, and packaging.
In the case of 0.9% Sodium Chloride eye drops failing to meet clarity standards, they are classified as level 3 because although no immediate serious risk has been observed, there is still a potential for eye irritation, reduced safety, or it reflects a problem in the manufacturing or storage process.
Dr. Nguyen Huy Hoang, from the Vietnam Society of Underwater Medicine and Hyperbaric Oxygen Therapy, stated that although the level of violation does not pose an immediate danger, it is still a cause for concern.
0.9% saline solution is a familiar product for eye hygiene, but it must meet two criteria: it must be sterile and completely clear. If the solution contains foreign particles or impurities, users may experience symptoms such as grittiness, burning, redness, tearing, or temporary blurred vision. Continued use risks repeated corneal abrasion, which can lead to dry eyes or corneal scarring in the long term.
Users should develop the habit of carefully checking products before use. A standard solution should be completely clear, colorless, free of suspended particles, and without any cloudiness or sediment. If the bottle appears slightly cloudy, discolored, or has deposits around the neck, discontinue use.
Doctors advise that, to ensure safety when using 0.9% Sodium Chloride eye drops, people should store the medication in a cool, dry place at room temperature, avoiding excessive heat and humidity.
Additionally, avoid direct sunlight, keep away from water sources or in the freezer, and keep out of reach of children and pets. Once opened, use the medicine immediately and close the bottle cap after use, ensuring the bottle cap remains clean.
In particular, focus on protecting your eyes from the inside out by getting enough sleep, supplementing with essential nutrients that are good for your eyes every day, allowing your eyes time to relax and rest, and avoiding staring at phone, computer, and TV screens for hours on end. After every 30 minutes of studying and working on a computer, you should take a 30-minute break.
Source: https://baovanhoa.vn/doi-song/vi-sao-thuoc-nho-mat-khong-dat-do-trong-230968.html
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