MCAZ recalls Azithromycin batch over quality concerns

THE Medicines Control Authority of Zimbabwe (MCAZ) has recalled Azithromycin 500mg USP Tablets, Batch Number: 24050191, manufactured by Indoco Remedies Limited, citing quality concerns.

The recall, which extends to retail level, follows a voluntary notification from the manufacturer after an out-of-specification (OOS) result was identified during dissolution testing conducted as part of a 24-month stability study.

Azithromycin is a widely used antibiotic for treating bacterial infections including bronchitis, pneumonia, sexually transmitted diseases, and infections of the ears, lungs, sinuses, skin, throat and reproductive organs. It is also used to treat or prevent disseminated Mycobacterium avium complex infections, particularly in people living with HIV.

In a statement, MCAZ said the defect points to non-compliance with approved product specifications.

“The 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 (OOS) result was identified during dissolution testing conducted as part of a 24-month stability study,” said the authority.

MCAZ warned that the quality issue may compromise the medicine’s effectiveness and could contribute to antimicrobial resistance if proper therapeutic levels are not achieved.

The authority urged healthcare professionals and pharmaceutical players to immediately stop distribution and use of the affected batch, while members of the public are advised to return the product to the point of purchase or consult healthcare providers for guidance.