The Drug Administration of Vietnam, under the Ministry of Health, has mandated a nationwide recall of a specific batch of Sodium Chloride 0.9% eye drops produced by Pharmedic Pharmaceutical Pharmaceutical Joint Stock Company.
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Registration Number: 893100060724.
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Batch Number: 10370725.
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Manufacture Date: July 14, 2025; Expiry Date: January 14, 2028.
Reason and Violation Level The recall was triggered because the product failed to meet quality standards regarding its clarity index. This discrepancy was confirmed through testing conducted by the Quang Ngai Provincial Drug Quality Control Center and the Ho Chi Minh City Institute of Drug Quality Control. The violation is categorized as Level 3, which refers to non-compliance that does not typically compromise therapeutic efficacy or patient safety but remains a breach of quality protocols.
Directives for Stakeholders
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Pharmedic Company: Must immediately cease trading, quarantine the affected batch, and notify all wholesale and retail partners of the recall. The collection and recovery of the batch must be finished within 30 days starting from May 11, 2026.
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Healthcare Facilities and Pharmacies: Must stop prescribing, selling, or dispensing the affected batch and return any remaining stock to their suppliers.
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Provincial Health Departments: Are tasked with overseeing the recall process and intensifying quality inspections of medicines currently in circulation.