The Medicines Control Authority of Zimbabwe (MCAZ) has announced a Class II recall of Azithromycin 500mg USP Tablets (Batch Number 24050191), produced by Indoco Remedies Limited in India, citing concerns over product quality that could affect treatment outcomes.
The decision, which applies up to the retail level, comes after the manufacturer voluntarily reported that the batch did not meet required standards during dissolution testing carried out as part of a 24-month stability assessment.
MCAZ explained that the out-of-specification (OOS) results point to a defect that may reduce the drug’s effectiveness in treating bacterial infections. There are also concerns that inadequate therapeutic levels could contribute to the development of antimicrobial resistance.
“All healthcare providers, including wholesalers, pharmacies, clinics, and hospitals, have been directed to isolate any affected stock immediately and work with the manufacturer and local distributors throughout the recall process,” the authority said.
Members of the public who may have purchased the affected tablets are encouraged to return them to the pharmacy where they were obtained. Patients who have already used the medication are advised to seek guidance from healthcare professionals.
MCAZ emphasized that it remains committed to safeguarding public health by ensuring that all medicines available in Zimbabwe meet strict standards for quality, safety, and effectiveness. The authority added that it will continue monitoring the situation and provide updates as needed.