Bulawayo, (New Ziana) — The Medicines Control Authority of Zimbabwe (MCAZ) has ordered an urgent nationwide recall of a batch of Azithromycin 500mg tablets after quality defects were detected, raising concerns over possible treatment failure and the risk of antimicrobial resistance.
In a statement on Wednesday, MCAZ director general, Richard Rukwata said that the recall affects Azithromycin 500mg USP Tablets, batch number 24050191, manufactured by Indoco Remedies Limited.
“The Authority received a critical communication from the manufacturer regarding an out-of-specification result in dissolution tests during a 24-month stability study.
“Such non-compliance with product quality standards may compromise the effectiveness of the medicine in treating bacterial infections,” said Rukwata.
Azithromycin is a widely used antibiotic for respiratory, skin and sexually transmitted infections.
MCAZ warned that substandard performance of the affected batch could lead to incomplete treatment, prolonged illness and contribute to the growing global threat of antimicrobial resistance.
The recall, classified as a Class II recall, extends up to retail level, meaning all distribution points including pharmacies, wholesalers, clinics and hospitals are required to immediately stop dispensing the affected batch.
MCAZ has directed all licensed wholesalers, pharmacies, and public and private health institutions to quarantine any remaining stock and cooperate fully with the manufacturer and local distributors to facilitate an efficient recall process.
Members of the public who may have purchased the affected batch are urged to return the medicine to the dispensing pharmacy and seek guidance from healthcare professionals, particularly if they are currently undergoing treatment or recently completed a course using the product.
Health experts said medicine recalls of this nature are part of routine pharmacovigilance systems designed to safeguard public health, but stress the importance of swift compliance by all stakeholders to minimise potential harm.
Zimbabwe, like many countries, continues to strengthen regulatory oversight in the pharmaceutical sector to ensure the safety, quality and efficacy of medicines on the market.
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