Urgent Nationwide Recall Issued for Specific Pain Medication Batch
The regulatory authority has ordered the recall of a Diclofen 50mg batch due to a quality failure (Related Substances), classified as a Level 2 violation.
The Drug Administration of Vietnam (under the Ministry of Health) has issued a decision mandating a nationwide recall for a specific batch of medication. The recalled product is Diclofen enteric-coated tablets (containing Diclofenac sodium 50mg), registration number VD-25150-16. The manufacturer is Pharmedic Pharmaceutical Joint Stock Company.
The affected batch details are: Lot number 0040724, manufactured on July 26, 2024, with an expiry date of July 26, 2027.
The recall was initiated after quality control testing revealed that the batch did not meet quality standards.
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Inspection Results: Both the Ho Chi Minh City Drug, Cosmetics, and Food Testing Center (on August 4, 2025) and the Ho Chi Minh City Drug Testing Institute (on December 1, 2025) confirmed that samples of the drug failed the Related Substances quality parameter.
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Violation Level: In accordance with Circular 30/2025/TT-BYT, this failure constitutes a Level 2 violation, indicating a quality defect that may potentially affect the drug’s efficacy and patient safety, thus requiring mandatory recall.
The Drug Administration has instructed Pharmedic Company to take strict actions:
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Immediate Cessation: Immediately cease all business activities related to the violating batch and quarantine all remaining stock.
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Reporting: Within 7 days, the Company must submit a detailed report on the distribution path, including all recipients (wholesalers, retailers, pharmacies, and hospitals).
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Complete Recall: The Company must proactively notify all medical establishments and users who have purchased the drug and organize a thorough retrieval of the entire batch. This recall process must be finalized within 15 daysfrom the effective date of the decision.
