BY MUNYARADZI BLESSING DOMA
The Medicines Control Authority of Zimbabwe (MCAZ) has warned all healthcare professionals, licensed pharmaceutical stakeholders and the general public of a Class II recall up to the retail level, of Azithromycin 500mg USP Tablets, Batch Number: 24050191, manufactured by Indoco Remedies Limited, India.
This recall follows a voluntary notification from the manufacturer after an out-of-specification (OOS) result was identified during dissolution testing conducted as part of a 24-month stability study.
In a statement, MCAZ Director General Richard Rukwata said the identified quality defect indicates non-compliance with approved product specifications, which may compromise the effectiveness of the medicine in treating bacterial infections and contribute to the development of antimicrobial resistance if therapeutic levels are not achieved.
“The Authority would like to draw the attention of all licensed wholesalers, pharmacies, public and private clinics, and hospitals that they should quarantine any of the affected units of the reported product and cooperate with Indoco Remedies Limited and local distributors of the product in Zimbabwe during the recall process.
“The general public who might have purchased the same reported batch are advised to return the product to the pharmacy where they obtained the medicine.
“Patients who recently used this product are advised to see their healthcare professionals for assistance,” said Rukwata.
Rukwata added that the Authority remains committed to safeguarding public health by ensuring that all medicines available in Zimbabwe meet the required standards of quality, safety and efficacy.
He reiterated that MCAZ will continue to monitor the recall process and provide updates where necessary.
Azithromycin is a widely used antibiotic for the treatment of various bacterial infections. It is warned that compromised quality medicines can reduce treatment effectiveness and increase the risk of antimicrobial resistance.
