FDA orders recall of drugs for acute gout

THE Food and Drug Administration (FDA) has ordered the immediate recall of specific lots of a drug product used to treat acute gout.

In its Advisory No. 2024-1080, the FDA issued a product recall order for “Colchicine 500 mcg Tablet” that has a registration number of DRP-7805, lot numbers PE09P and PF03P, and expiration dates of May 2025 and June 2025.

Colchicine is used for the treatment of acute gout and for short term prophylaxis during initial therapy with allopurinol and uricosuric drugs.

“All healthcare professionals and the general public are hereby warned by the Food and Drug Administration that the affected lots of the subject product are being recalled from the market,” said the FDA.

Citing laboratory analyses, the FDA said the product has been found to have insufficient quantity of active pharmaceutical ingredients.

“Its consumption may lead to underdosing and cause possible mistreatment,” it warned, as it appealed to all FDA consumers not to use or purchase the affected lots of the subject product.

Those who have consumed the product, on the other hand, are encouraged to immediately report any suspected adverse reaction experienced from its use.

The FDA ordered distributors, hospitals, retailers, or pharmacies that have the said product being recalled to stop their distribution, sale, and use.