Gout Medication 'Colchicine' Recalled Nationwide for Quality Failures

The Drug Administration of Vietnam has ordered a nationwide recall of all batches of the gout medication 'Colchicine' due to quality failures. The affected batches are for Colchicina Seid (Colchicine 1 mg), which failed to meet quality standards for dissolution and several other indicators. A report from the National Institute of Drug Testing in early September confirmed that supplementary tests on this batch did not meet the dissolution standard. Previously, specialized agencies collected comparison samples at Quynh Lan Pharmaceutical Co., Co., Ltd. (Hanoi) and discovered that the product violated numerous criteria, including sensory properties, dissolution, content uniformity, and active ingredient quantification. These violations were classified as Level 2. According to pharmaceutical regulations, Level 2 violations refer to the state where a drug does not meet quality standards for technical indicators that constitute the tablet. This level does not cause acute poisoning or immediate life-threatening conditions, but it reduces the ability of the active ingredient to be released into the bloodstream, leading to the drug losing its effectiveness in suppressing acute gout pain or increasing the risk of side effects when patients self-medicate by increasing the dosage. The recalled batch bears the marketing authorization number VN-22254-19, batch number V008, manufactured on May 20, 2024, with an expiry date of May 20, 2029. The manufacturer is Seid, S.A. (Spain), and the importer is Nhat Anh Pharmaceutical Co., Ltd. The active ingredient Colchicine plays a specific anti-inflammatory role, commonly prescribed by doctors to cut off severe joint pain during acute gout attacks and for relapse prevention. This medication is widely available. The exact quantity to be recalled is currently unknown. The Drug Administration has compelled Nhat Anh Pharmaceutical Co., Ltd. to recall all quantities of batch V008 that have been distributed. Hospitals, clinics, pharmacy chains, and wholesale agents nationwide must immediately stop prescribing, dispensing, seal their inventory, and return the products to the supplier. Regulatory authorities advise patients currently using Colchicina Seid to immediately check the batch number printed on the product 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.