Gout Medication Recalled

Zydus Pharmaceuticals USA Inc is recalling 4 lots of colchicine tablets after testing revealed one lot was out of specification for the related substance beta-Lumicolchicine, according to the March 22, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured for NorthStar Rx, Memphis, Tennessee, by Zydus Lifesciences Ltd, Ahmedabad, India:

• colchicine tablets 0.6 mg, 30-tablet bottles (NDC 16714-0039-01), from lot E203821 (Exp 5/24); and
• colchicine tablets 0.6 mg, 100-tablet bottles (NDC 16714-0039-02), from lots E203822 (Exp 5/24) and E206186 (Exp 10/24).

Also included in the recall are colchicine tablets 0.6 mg, 100-tablet bottles (NDC 70710-1351-01), manufactured by Cadila Healthcare Ltd, Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc, Pennington, NJ. The affected tablets are from lot E203820 (Exp 5/24).

All colchicine tablets included in the recall were distributed in Arizona, Ohio, and Mississippi.

Zydus Pharmaceuticals voluntarily initiated the recall February 24, 2023. On March 14, 2023, the FDA designated the recall Class III, suggesting use of the medication is not likely to cause harm.

Colchicine is a prescription medication indicated for prophylaxis and the treatment of acute gout flares, or for the treatment of familial Mediterranean fever.