The Pharmacy and Poisons Board (PPB) has issued a recall of Flamodip tablets, batch number FLD 303, manufactured by Medico Remedies, due to a labeling error.
The recall, announced by the PPB highlights concerns that the mislabeling could potentially pose a risk to patients who are prescribed the drug for hypertension and related conditions.
According to the PPB statement,the outer packaging of the affected tablets is labeled as Flamodip-5 (Amlodipine), while the inner packaging incorrectly identifies the medication as Flamodip-5 (Enalapril).
According to the regulator, the discrepancy is significant because both medications are used to treat high blood pressure, but they function differently and are prescribed for different conditions.
“The secondary packaging is labeled as Flamodip-5 (Amlodipine), while the first packaging is labeled as Flamodip-5 (Enalapril),” the PPB said in a statement.
Amlodipine is commonly prescribed to treat high blood pressure in adults and children over six years old, as well as to manage angina (chest pain) and coronary artery disease.
Enalapril, on the other hand, is used to treat high blood pressure and heart failure. The confusion between the two drugs could potentially lead to patients receiving incorrect treatment, with adverse health consequences.
The PPB has urged the public to stop using the affected batch immediately and report any adverse reactions or suspected and or sub-standard drugs.
“Members of the public are encouraged to report any cases of sub-standard medicine or adverse drug reactions to the nearest healthcare facility or directly to the PPB through our online portal or USSD code,” the statement added.
Patients and healthcare professionals are advised to remain vigilant and ensure the correct medication is dispensed to avoid any harmful effects.
The public can report any issues through the PPB’s online platform at https://pv.pharmacyboardkenya.org/users/mpublic or via the USSD code *271#.
