NAFDAC Recalls Regpara Tablets Over Cancer-Causing Impurity

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert concerning the recall of certain batches of Regpara Tablets 25mg, produced by DKSH Hong Kong Limited, due to the presence of a harmful impurity.

According to the manufacturer, the affected tablets contain N-nitroso-cinacalcet, a substance classified as a probable human carcinogen, which exceeds acceptable daily intake levels. The impurity was detected during quality testing, prompting the precautionary recall.

Regpara Tablets, containing the active ingredient cinacalcet, are prescription drugs primarily used for treating secondary hyperparathyroidism in dialysis patients.

NAFDAC warns that the consumption of contaminated medicines can pose serious health risks, including life-threatening conditions. Though the recalled products are not listed in NAFDAC’s official database, the agency is urging all stakeholders, importers, distributors, retailers, healthcare providers, and patients to remain vigilant.

The agency emphasized the importance of sourcing medications only from authorized and licensed suppliers, and advised the public to carefully examine the physical condition and authenticity of any medical product.

Healthcare professionals and the general public are encouraged to report any suspected cases of substandard or falsified medicines to NAFDAC via the toll-free number 0800-162-3322, by email at sf.alert@nafdac.gov.ng, or through the Med-Safety mobile app. Reports of side effects or adverse events should be submitted using the same channels or directly through the Pharmacovigilance unit at pharmacovigilance@nafdac.gov.ng.