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Recall of Sure Lubricated Condoms Dotted
 
The Pharmacy and Poisons Board (PPB) in collaboration with the National STI and AIDS Control Program (NASCOP) conducted a joint post-market surveillance quality survey of selected medical products and health technologies used in Kenya. Among the products that were sampled and tested were male latex condoms. The laboratory analysis results indicated that the following male latex condoms failed to comply with specification (s) for ISO 4074:2015 standard;
  Condom Batch Manufacturer
1. SURE LUBRICATED CONDOMS DOTTED 17DN052, 17DN754 Innolatex (Thailand) Limited
2 SURE LUBRICATED CONDOMS L48058, P48045, P48001, L48037, P48027, L48110 HLL Lifecare Limited, INDIA
3 SURE LUBRICATED CONDOMS 1601957422 Suretex Prophylactics (India) Limited
 
The non-compliance is batch specific and does NOT impact the entire product of SURE CONDOMS. PPB has put in mechanisms to ensure quality and safety of condoms circulating in Kenya in addition to ordering recalls of all the impacted batches of the SURE condoms.
Pharmacy and Poisons Board has a robust post-market surveillance system that includes routine quality surveys, where samples of different medicine and medical devices categories are collected from different levels of pharmaceutical outlets and health facilities, and the samples are subjected to laboratory analysis to check the quality of the product. This is done based on the product specifications that were applied during registration of the individual products.
 
 
CHIEF EXECUTIVE OFFICER
3RD OCTOBER 2019

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