Zimbabwe: MCAZ Orders Recall of Azithromycin Batch Over Quality Defect, Patients Urged to Return Stock

THE Medicines Control Authority of Zimbabwe (MCAZ) has ordered the recall of a batch of a widely used antibiotic Azithromycin after it failed quality tests.

Zimbabwe's medicines regulator said the recall affects Azithromycin 500mg USP Tablets, Batch Number 24050191, manufactured by Indoco Remedies Limited.

In a statement Monday, MCAZ said the recall which extends up to retail level, follows a voluntary notification by the manufacturer after the product failed dissolution testing during a 24-month stability study.

Pharmacies and clinics have been ordered to isolate the affected stock.

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"MCAZ wishes to inform 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 result was identified during dissolution testing.

"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," MCAZ said.

The public has been urged to immediately return the product to pharmacies where they purchased it.

"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," MCAZ added.

MCAZ said it will continue monitoring the recall process and provide updates where necessary.

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