Michael Gwarisa
The Medicines Control Authority of Zimbabwe (MCAZ) has issued a Class II recall of a specific batch of Azithromycin 500mg USP tablets after a quality defect was detected, raising concerns over the drug’s effectiveness in treating bacterial infections.
The affected product, Batch Number 24050191, was manufactured by Indoco Remedies Limited of India. According to MCAZ, the recall extends up to the retail level, meaning wholesalers, pharmacies, clinics, and hospitals are all required to take immediate action to remove the product from circulation.
“This recall follows a voluntary notification from the manufacturer after an out-of-specification result was identified during dissolution testing conducted as part of a 24-month stability study,” said MCAZ Director-General Mr. Richard T. Rukwata.
The authority explained that the defect indicates non-compliance with approved product specifications, which could compromise the medicine’s ability to effectively treat infections. Inadequate drug performance may also contribute to antimicrobial resistance, a growing global health threat, if patients do not achieve the required therapeutic levels.
Healthcare providers and pharmaceutical stakeholders have been instructed to quarantine any remaining stock of the affected batch and cooperate fully with the manufacturer and local distributors during the recall process. This includes ensuring that no further units are dispensed to patients.
Members of the public who may have purchased the recalled medication are advised to return it to the pharmacy where it was obtained. Patients who have recently used the product are encouraged to seek guidance from healthcare professionals, particularly if they have concerns about treatment effectiveness.
MCAZ reaffirmed its commitment to protecting public health by ensuring that all medicines in Zimbabwe meet strict standards of quality, safety, and efficacy. The authority added that it will continue to monitor the recall and provide updates as necessary.
