HARARE, Apr. 13 (Newsday Live) - The Medicines Control Authority of Zimbabwe (MCAZ) has recalled a batch of Azithromycin 500mg tablets manufactured by India-based multinational pharmaceutical company Indoco Remedies Ltd after the product failed to meet required quality standards, raising concerns over its effectiveness in treating bacterial infections.
The recall follows a voluntary notification by the manufacturer after an out-of-specification (OOS) result was detected during dissolution testing conducted as part of a 24-month stability study.
MCAZ said the recall is classified as a Class II measure, meaning the product defect may cause temporary or medically reversible adverse health effects, while also posing a risk of reduced therapeutic efficacy.
The quality defect indicates non-compliance with approved product specifications and may compromise the medicine’s effectiveness in treating bacterial infections. Authorities also warned that sub-therapeutic dosing could contribute to antimicrobial resistance.
In a statement issued yesterday, MCAZ said the affected batch is being withdrawn from circulation as part of ongoing drug safety monitoring and quality assurance measures.
The Authority urged all licensed wholesalers, pharmacies, and both public and private health institutions to immediately isolate the affected stock.
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“The Authority would like to draw the attention of all licensed wholesalers, pharmacies, public and private clinics, and hospitals to quarantine any affected units of the reported product and cooperate with Indoco Remedies Limited and local distributors in Zimbabwe during the recall process,” read the statement.
Members of the public who may have purchased the affected batch are advised to return it to the dispensing pharmacy.
“Patients who have recently used this product should consult their healthcare professionals for assistance,” MCAZ said.
The Authority reaffirmed its commitment to safeguarding public health and ensuring compliance within the pharmaceutical sector.
“MCAZ will continue to monitor the recall process and provide updates where necessary,” the statement said. Pair in court over bid to smuggle crystal meth to South East Asia