NAFDAC Issues Recall of Hypertension Drug Cardura XL On Quality Concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of two specific lots of Cardura XL (Doxazosin) extended-release tablets, a medication commonly prescribed for the management of hypertension and benign prostatic hyperplasia (BPH).

The affected drug, manufactured by Viatris Inc., a leading global pharmaceutical and healthcare company based in the United States, failed to meet critical impurity and degradation specifications.

According to the Agency’s statement posted in its official X Handle (formerly Twitter) seen by The WHISTLER, the recall affects two lots of Cardura XL, with lot numbers 81470418163765 and 81470408163764, covering both the 8mg and 4mg extended-release tablet formulations.

NAFDAC noted that these lots are being recalled as a precautionary measure after routine quality checks identified impurities and degradation beyond acceptable limits. This action is aimed at ensuring the safety and efficacy of medications available in the Nigerian market.

Cardura XL, containing the active ingredient doxazosin mesylate, is an alpha-adrenergic blocker commonly prescribed for controlling high blood pressure (hypertension).

The medication is also widely used to improve urinary symptoms in men suffering from benign prostatic hyperplasia (BPH), a condition associated with the enlargement of the prostate gland.

NAFDAC urged healthcare professionals, pharmacists, and patients currently using the affected lots of Cardura XL to stop the administration and return any unused tablets to the nearest pharmacy or healthcare provider.

In addition, the regulatory agency advised medical professionals to consider alternative treatment options for patients currently prescribed the affected medication.

NAFDAC has also requested that consumers and healthcare professionals report any suspicion of substandard or falsified medicines through its dedicated reporting channels.

According to the agency, concerns can be raised via the toll-free number 0800-162-3322 or by email at [email protected].

The recall is part of NAFDAC’s ongoing commitment to safeguarding public health and ensuring that only high-quality, safe, and effective medications are available to consumers in Nigeria.