The Pharmacy and Poisons Board (PPB) has issued an urgent warning regarding the presence of substandard and falsified medicines currently circulating within the Kenyan pharmaceutical market. In a statement released on Thursday, Fred Siyoi, the Chief Executive Officer of the regulatory body, disclosed that several compromised pharmaceutical products have been identified, raising significant concern for patient safety across the country.
The most alarming discovery involves multiple batches of Paracetamol injections that have demonstrated unusual physical changes, including unexpected discoloration, which signals potential compromise in their quality and safety. The specific products under scrutiny include Lumidol Injection, Blink Injection, and Paragen Injection, all of which are manufactured by KamlaAmrut Pharmaceutical LLP based in India. The affected batches are CM4594007, CM4594008, CM4594009 for Lumidol; C84594005 and CS4594004 for Blink; and K4290027 for Paragen. Given the critical use of Paracetamol in pain and fever management, this issue poses a serious risk, especially in hospital settings where injectable medication is often administered to vulnerable patients.
In addition to the Paracetamol recall, a serious packaging error has been reported involving the drug Esomeprazole. A batch of S-Prazo (Esomeprazole 40mg), bearing the batch number SPZ404, was found to contain a strip of Levofloxacin 500mg tablets instead of the intended capsules. This type of product mix-up could lead to harmful consequences, particularly if taken by patients who are allergic to Levofloxacin or are not intended to receive antibiotic treatment. Such errors not only compromise therapeutic outcomes but also erode public trust in pharmaceutical quality assurance processes.
The issue extends further with the discovery of falsified Augmentin products in the market. The falsified batches include AUGMENTIN 1G (Batch SGS2) and AUGMENTIN 625mg (Batches 8X3K and EU7C). These counterfeits have been confirmed to be circulating and pose a high risk due to the possible lack of active ingredients or contamination with harmful substances. Augmentin is a widely used antibiotic that treats various bacterial infections, and the use of a falsified version could lead to treatment failure or the development of antibiotic resistance.
In light of these findings, the PPB has directed all pharmaceutical distributors, healthcare providers, and the general public to cease the distribution, sale, and use of the flagged products immediately. The Board has instructed that any of the listed medications in circulation should be returned to the nearest licensed health facility or supplier for safe disposal. It is also encouraging the public to remain vigilant and report any suspicious medicines or adverse reactions through official reporting channels or by visiting the nearest healthcare provider.
The PPB continues to reinforce its commitment to safeguarding public health through strict regulatory oversight and timely interventions. As part of this ongoing initiative, enhanced surveillance and quality assurance mechanisms have been put in place to prevent the recurrence of such incidents. With the increasing threat of substandard and falsified medicines globally, the Board urges all stakeholders to cooperate fully in ensuring that only safe, effective, and quality medicines are available in the Kenyan market.
