Zimbabwe Recalls Antibiotic Batch Over Quality Concerns

By Tinomudaishe Muzanenhamo

The Medicines Control Authority of Zimbabwe (MCAZ) has ordered the recall of a batch of Azithromycin 500mg tablets after identifying defects that could reduce the drug's effectiveness in treating bacterial infections.

In a statement, the regulator said the affected batch numbered 24050191 was produced by Indoco Remedies Limited and is being withdrawn up to retail level.

The recall follows a voluntary alert by the manufacturer after routine stability testing revealed the medicine did not meet required standards. MCAZ said the issue was detected during a 24-month study, specifically in dissolution testing which assesses how a drug releases its active ingredient in the body.

Failure in this test raises concerns that patients may not receive the intended dosage potentially reducing treatment effectiveness and increasing the risk of antimicrobial resistance.

"The identified quality defect indicates non-compliance with approved product specifications, which may compromise the effectiveness of the medicine," the authority said.

MCAZ has instructed wholesalers, pharmacies, hospitals and clinics to immediately isolate any stock from the affected batch and assist in the recall process.

Patients who may have purchased the product are being urged to return it to the point of sale while those who have recently used it are advised to seek medical advice.

The regulator said it would continue to monitor the situation adding that the move reflects its mandate to ensure medicines available in Zimbabwe meet required standards of safety, quality and efficacy.

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