The drug regulatory body has recalled a brand of condoms after it failed a quality test.
The Pharmacy and Poisons Board (PPB) said the recall only affects specific batches of Sure condoms.
The recalled products include Sure lubricated condoms with batch numbers 17DN052 and 17DN754. They are manufactured in Thailand by Innolatex Limited.
The others are Sure lubricated condoms batch numbers LP8058, P48045, P48001, L48037, P48027 and L48110, as well as Sure lubricated condoms batch number 1601957422. These are manufactured in India.
The PPB said it carried out the quality tests in a routine joint post-market surveillance with the National STI and AIDS Control Programme.
Among the products that were sampled and tested were the male latex condoms.
The PPB said laboratory analysis results indicated that the listed male latex condoms failed to comply with the specifications for ISO 4074:2015.
Batch specific
“The non-compliance is batch specific and does not impact the entire product of Sure condoms,” said PPB.
The board said it has put mechanisms in place to ensure the quality and safety of condoms circulating in Kenya.
It added that it has a “robust” post-market surveillance system that includes routine quality surveys where samples of different categories of medicine and medical devices are collected from different pharmaceutical outlets and health facilities.