NAIROBI, Kenya — The Pharmacy and Poisons Board has warned Kenyans against a falsified batch of the emergency contraceptive Postinor-2 detected in circulation in the country, saying the product may not provide the intended therapeutic effect.
The regulator said the affected product is levonorgestrel 0.75mg tablets, batch number T34197R, which has been misleadingly presented and marketed as genuine Postinor-2.
The warning comes after the Board identified the suspected counterfeit during its post-marketing surveillance activities, which monitor health products circulating in the Kenyan market.
The regulator said a comparison between the suspected falsified product and genuine Postinor-2 revealed several inconsistencies in the packaging and presentation.
“These differences strongly indicate that batch T34197R is falsified and was not manufactured or released as a genuine product,” the Board said.
Regulator identifies packaging differences
According to the Board, investigators found differences in the batch-printing method, as well as printing and typographical errors on the Patient Information Leaflet.
The carton sealing method also differed from that used on genuine Postinor-2 packaging.
The regulator further noted that the orange colour used on the brand name and other areas of the packaging was significantly more intense than that of the genuine product.
Another difference was identified on the authentication panel. The font of the logo revealed after scratching the panel was different from the font used on genuine packaging.
The Board said the cumulative differences provided strong evidence that batch T34197R was not an authentic Postinor-2 product.
Two people arrested
The regulator said the falsified product had been found in circulation in the Kenyan market and that two people had been arrested after being found in possession of the suspected falsified medicines.
Multi-agency investigations are continuing to establish the product’s source, point of entry into Kenya and extent of distribution through the supply chain.
The arrests come as the regulator intensifies action against the illegal manufacture, importation, distribution and supply of falsified health products.
The Board said it would take firm regulatory and legal action against anyone found to be involved in the circulation of falsified medicines.
Why the warning matters
The Pharmacy and Poisons Board warned that falsified medicines can pose serious risks because their contents may not correspond with what is stated on the packaging.
It said the falsified Postinor-2 batch may contain an incorrect amount of the active ingredient levonorgestrel, no active ingredient at all, harmful contaminants or undeclared substances.
As a result, the product may fail to provide the intended therapeutic effect.
For an emergency contraceptive, the warning is particularly significant because effectiveness depends on receiving the correct active ingredient at the appropriate dose and within the recommended timeframe.
The regulator has therefore urged members of the public to exercise caution when purchasing or using the affected product.
Pharmacists told to quarantine suspected stock
Healthcare professionals have been instructed to verify the authenticity of Postinor-2 stocks before dispensing them to patients.
The Board said any suspected falsified products should be quarantined immediately and reported to the relevant authorities.
Procurement agencies, hospitals, distributors, pharmacists and pharmaceutical technologists have also been urged to report any encounter with batch T34197R.
Members of the public who come across the suspected falsified batch have similarly been encouraged to alert the regulator.
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The advisory is intended to help investigators establish how widely the product has circulated and prevent further distribution while the investigation continues.
Board warns against unlicensed suppliers
The Pharmacy and Poisons Board has further urged stakeholders across the pharmaceutical supply chain to obtain medicines and other health products only from licensed manufacturers, importers, distributors and retailers.
The regulator warned that purchasing medicines from unlicensed sources puts patients at risk and violates Kenya’s pharmaceutical laws.
“Procuring from unlicensed sources endangers patients and constitutes a violation of the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya,” the Board said.
The regulator said the investigations into the falsified Postinor-2 were at an advanced stage as authorities worked to establish the full supply chain through which the product entered and circulated in Kenya.
For now, the Board’s warning is specifically focused on levonorgestrel 0.75mg tablets bearing batch number T34197R.
Kenyans who encounter the affected batch should avoid using or dispensing it and report it to the relevant pharmaceutical authorities, while healthcare providers and suppliers have been urged to verify their stocks and isolate any suspected falsified products.
