The National Agency for Food and Drug Administration and Control (NAFDAC) has renewed its public health alert over a counterfeit batch of Herceptin® 600mg/5ml (Trastuzumab Solution for Injection) circulating in Ghana and allegedly sourced from Nigeria.

The alert, active on the agency’s website and reposted on Thursday, was reported by Nairametrics and highlights the serious risks posed by the fake oncology drug.

The counterfeit product, identified by batch number A8519, does not match any authentic batch produced or distributed by Roche, the original manufacturer.

NAFDAC revealed, “This counterfeit was reportedly presented by a patient at a hospital in Kumasi, who claimed to have purchased it in Nigeria.”

Herceptin® 600mg/5ml is prescribed for breast cancer patients whose tumors test positive for HER2.

The agency explained, “It may be administered alone or alongside other treatments for breast cancer, such as an aromatase inhibitor for hormone receptor-positive breast cancer or a taxane, like paclitaxel or docetaxel.”

NAFDAC outlined several indicators of the counterfeit, including the invalid batch number (A8519), irregular font types, misaligned label text, inconsistent data, and tamper-evident seals that differ from those on genuine Roche packaging.

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The agency warned that the fake product may contain substandard, falsified, or no active pharmaceutical ingredient at all, rendering treatment ineffective.

“Unknown chemical contents pose a risk of adverse drug reactions, including allergic reactions, systemic toxicity, or other severe health outcomes. Use of falsified oncology products compromises the integrity of therapeutic regimens, potentially leading to disease progression or mortality,” NAFDAC stated.

All zonal directors and state coordinators have been instructed to intensify surveillance and remove any counterfeit Herceptin® 600mg/5ml found within their jurisdictions.

NAFDAC urged distributors, retailers, healthcare professionals, and caregivers to remain vigilant across the supply chain to prevent the distribution and use of fake medicines.

“All medical products must be obtained from authorized or licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” the agency advised.

Healthcare professionals and consumers are encouraged to report suspected cases of substandard or falsified medicines or medical devices to the nearest NAFDAC office or through the e-reporting platforms available at www.nafdac.gov.ng.

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