The Pharmacy and Poisons Board (PPB) has issued a nationwide public alert warning Kenyans against using a falsified batch of Postinor-2 (Levonorgestrel 0.75mg) emergency contraceptive tablets that has been detected in circulation within the local market. The regulator says the counterfeit product poses potential health risks and may fail to provide the intended contraceptive effect.
According to the PPB, the affected product bears batch number T34197R and falsely claims to have been manufactured by Gedeon Richter Plc, the legitimate manufacturer of Postinor-2. The Board said investigations established that the batch is falsified and was neither manufactured nor released by the pharmaceutical company.
The alert follows routine post-marketing surveillance conducted by the medicines regulator to monitor the quality, safety and authenticity of health products available in Kenya. During the inspection, officials identified several inconsistencies between the suspected counterfeit product and genuine Postinor-2 tablets supplied by Gedeon Richter Plc.
In its advisory, the PPB said differences were noted in the way the batch number was printed, the patient information leaflet contained multiple printing and typographical errors, and the carton packaging used a different sealing method from authentic products. The regulator also observed that the counterfeit packaging had a noticeably darker orange colour and a different font beneath the authentication panel compared with genuine packs.
“These observations strongly indicate that the product is falsified and is not manufactured or released by Gedeon Richter,” the Board said.
The Board warned that counterfeit medicines may contain incorrect amounts of the active ingredient, no active ingredient at all, harmful contaminants or undeclared substances. As a result, users of the falsified emergency contraceptive may not receive the intended protection against unintended pregnancy and could face additional health risks.
“This batch of falsified Postinor-2 may contain incorrect amounts of the active ingredient, no active ingredient at all, harmful contaminants, or undeclared substances, and therefore may not provide the intended therapeutic effect,” PPB said in the public alert.
The regulator has advised hospitals, procurement agencies, distributors, pharmacists and pharmaceutical technologists to verify the authenticity of their Postinor-2 stocks before dispensing them. Healthcare providers have also been instructed to immediately quarantine any suspected falsified products and report them to the Board.
Members of the public have been urged to purchase medicines only from PPB-licensed manufacturers, importers, distributors and pharmacies, warning that obtaining medicines from unlicensed sources increases the risk of exposure to counterfeit products and violates the Pharmacy and Poisons Act.
The Board further disclosed that, working alongside government investigative and enforcement agencies, it has made progress in tracing the counterfeit batch. According to the regulator, two individuals have been arrested after they were found in possession of the falsified product, while investigations continue to establish the source of the medicines, how they entered the country and the extent of their distribution within the supply chain.
PPB said it will continue taking regulatory and legal action against anyone found to be involved in the manufacture, importation, distribution or sale of falsified medicines, noting that counterfeit pharmaceutical products remain a significant public health concern because they can undermine treatment outcomes and expose patients to preventable health risks.
The regulator has encouraged healthcare professionals and members of the public who encounter the affected batch number T34197R to report it immediately through its official reporting channels, including its online pharmacovigilance portal, the USSD code *271#, the mPvERS mobile application, email or telephone hotline.