Nationwide recall of failed batches of Colchicina Seid gout treatment medicine

The Drug Administration of Vietnam requested a nationwide recall of Colchicina Seid (Colchicine 1 mg) because it did not meet quality standards for solubility and a number of other criteria.

A report in early September from the Central Institute of Drug Testing confirmed that additional testing samples for this batch of drugs did not meet the solubility standards.

Previously, the specialized agency took control samples at Quynh Lan Pharmaceutical Company Limited (Hanoi) and discovered that the product violated a series of criteria including sensory properties, solubility, content uniformity and active ingredient quantification. The management agency classified these violations as level 2.

According to pharmaceutical industry regulations, a level 2 violation refers to a condition in which the drug does not meet the quality standards in the technical specifications for constituting tablets. This level does not cause acute poisoning or immediate death threat, but reduces the ability to release active ingredients into the blood, causing the drug to lose its effectiveness in suppressing acute gout pain or increasing the risk of side effects when the patient has to arbitrarily increase the dose.

The batch of infringing medicine carries circulation registration number VN-22254-19, batch number V008, manufactured on May 20, 2024, expiry date until May 20, 2029. The manufacturing enterprise is Seid Company, S.A. (Spain), the importer is Nhat Anh Pharmaceutical Company Limited. The active ingredient Colchicine plays a specific anti-inflammatory role, often prescribed by doctors to relieve severe joint pain during acute gout attacks and prevent recurrence. This is a widely sold drug. It is unclear how many were recalled.

The Drug Administration of Vietnam forced Nhat Anh Company to recall the entire quantity of drugs belonging to batch V008 that it had distributed. Hospitals, clinics, pharmacy chains and wholesalers nationwide must immediately stop prescribing, dispensing, sealing inventory and returning products to suppliers.

The regulatory agency recommends that patients using Colchicina Seid immediately check the batch number information printed on the box. In case the batch number V008 matches, the user stops taking the medicine immediately and brings the product to the pharmacy to exchange or receive instructions on replacing the treatment regimen.