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The Pharmacy and Poisons Board (PPB) has issued a public health alert after identifying a falsified batch of a cancer medication circulating in the Kenyan pharmaceutical market.
PPB warns that the breast cancer drug poses a serious risk to patient safety and public health.
In a statement, the regulator Acting PPB Chief Executive Officer Dr Ahmed Mohamed said the counterfeit product is labeled as Phesgo (Pertuzumab/Trastuzumab) 600mg/600mg in 10ml, Batch Number C5290S20, but does not match any authentic manufacturer records.
The agency raised alarm over significant discrepancies between the fake product and the genuine formulation, noting that the falsified version contains a white powder instead of a liquid solution.
“The falsified batch contains discrepancies compared to the genuine Phesgo as follows: Batch number C5290S20 does not correspond to any authentic Roche batch number,” said Dr Mohamed.
“The vial contains a white powder, whereas genuine Phesgo is a ready-to-use, clear opalescent, colourless to slightly brownish liquid solution intended for subcutaneous administration,” he explained.
PPB further warned that the presence of a powdered formulation is a major red flag, since authentic Phesgo is never supplied in powder form and does not require reconstitution before use.
“Phesgo is never supplied as a powder and does not require reconstitution,” Dr Mohamed added.
The regulator cautioned that the falsified product may contain unknown or harmful ingredients, with no guarantees regarding its quality, safety, or efficacy.
“The falsified batch may contain incorrect, insufficient or harmful ingredients and its quality, safety and efficacy cannot be guaranteed. Use of this product poses a serious risk to patient safety and public health,” PPB warned.
In response, the Board has directed all healthcare providers, pharmaceutical technologists, procurement agencies, wholesalers, retailers, and members of the public to immediately stop the distribution, sale, and use of the affected batch.
“Public advisory: procurement agencies, distributors, wholesalers and retailers, pharmaceutical technologists, all healthcare professionals and members of the public should immediately stop the distribution and use of the falsified batch,” he said.
The Board also urged stakeholders within the pharmaceutical supply chain to strictly source medicines from licensed manufacturers and authorised distributors, warning that illegal procurement channels endanger patients and violate Kenyan law.
“All stakeholders within the supply chain should procure health products and technologies exclusively from licensed manufacturers, importers, distributors, and retailers,” PPB emphasized.
Dr Mohamed said authorities, working with other investigative agencies, will take firm action against those involved in the distribution of falsified medicines.
“The Board and relevant government investigative agencies will take firm action against anyone or entity involved in the distribution of this and any other falsified batches of health products and technologies,” said Dr Mohamed.
Kenya has in recent years intensified surveillance against counterfeit and substandard medicines, especially those targeting high-cost treatments such as cancer therapies.
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