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Vietnam recalls batch of Colchicine gout medication
The Drug Administration of Vietnam has ordered a nationwide recall of a specific batch of Colchicina Seid 1mg tablets due to a level 2 quality violation. The medication, which contains colchicine and is primarily used to treat and prevent acute gout attacks, failed to meet quality standards during testing.
The affected product is batch number V008, manufactured on May 20, 2024, with an expiration date of May 20, 2029. The tablets were produced by Seid, S. A. in Spain and imported by Nhất Anh Pharmaceutical Co., Ltd.
Testing conducted by the National Institute of Drug Quality Control revealed failures in several criteria, including properties, dissolution, content uniformity, and assay. Subsequent supplementary testing confirmed issues with dissolution levels.
Nhất Anh Pharmaceutical Co., Ltd. has been instructed to immediately cease business of the batch, quarantine remaining stock, and report distribution details to the Drug Administration and the Hanoi Department of Health within seven days. The company is also responsible for notifying wholesalers, retailers, medical facilities, and users to complete the recall within 15 days.
Entities
Drug Administration of Vietnam · National Institute of Drug Quality Control · Nhất Anh Pharmaceutical Co., Ltd. · Seid, S. A.