The Drug Administration of Vietnam has ordered a nationwide recall of a batch of Colchicina Seid (Colchicine 1 mg) medication. This decision follows a report on 25/8 from the National Institute of Drug Quality Control, confirming that additional test samples for the drug batch, specifically batch number V008, failed dissolution standards.
Previously, a specialized agency collected reference samples at Quynh Lan Pharmaceutical Co., Ltd. in Hanoi. The samples revealed the product violated several quality parameters, including sensory properties, dissolution, content uniformity, and the assay of the active ingredient. The regulatory body classified these violations as level 2.
According to pharmaceutical industry regulations, level 2 violations indicate a drug fails quality standards in the technical parameters of a tablet. While this level does not cause acute poisoning or immediate life-threatening danger, it reduces the release of the active ingredient into the bloodstream. This can cause the drug to lose effectiveness in suppressing acute gout attacks or increase the risk of side effects if patients self-increase their dosage.
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Label of the recalled drug batch due to substandard quality. Screenshot |
Label of the recalled drug batch due to substandard quality. Screenshot
The violating drug batch has circulation registration number VN-22254-19, batch number V008. It was manufactured on 20/5/2024 and expires on 20/5/2029. The manufacturer is Seid, S.A. from Spain, and the importer is Nhat Anh Pharmaceutical Co., Ltd. The active ingredient, colchicine, is a specific anti-inflammatory agent commonly prescribed by doctors to alleviate severe joint pain during acute gout attacks and prevent recurrence.
The Drug Administration of Vietnam compelled Nhat Anh Pharmaceutical Co., Ltd. to recall all distributed medication from batch V008. Hospitals, clinics, pharmacy chains, and wholesale distributors nationwide must immediately cease prescribing and dispensing, seal existing stock, and return the product to the supplier.
The regulatory agency advised patients currently using Colchicina Seid to immediately check the batch number printed on the box. If the batch number matches V008, users should stop taking the medication immediately and bring the product to a pharmacy for exchange or to receive guidance on an alternative treatment regimen.
Le Nga
