HomeLatestMCAZ recalls Azithromycin batch over quality concerns

MCAZ recalls Azithromycin batch over quality concerns

The Medicines Control Authority of Zimbabwe (MCAZ) has announced an urgent recall of a specific batch of Azithromycin 500mg USP tablets after a quality issue was discovered during routine stability testing.

The affected batch, numbered 24050191, was manufactured by Indoco Remedies Limited.

According to MCAZ, the recall—classified as Class II and extending to the retail level—was triggered by an out-of-specification result found during dissolution testing conducted as part of a 24-month stability assessment. This means the medicine may not release its active ingredient properly, potentially reducing its effectiveness.

The authority warned that the defect could impact the drug’s ability to adequately treat bacterial infections. Incomplete treatment may also increase the risk of antimicrobial resistance if patients do not achieve the required therapeutic levels.

MCAZ has instructed all licensed distributors, pharmacies, clinics, and hospitals to immediately isolate any stock from the affected batch and work closely with the manufacturer and local distributors to facilitate the recall.

Members of the public who have purchased Azithromycin from this batch are advised to return it to the pharmacy where it was obtained. Those who have already used the medication are encouraged to consult a healthcare professional for guidance.

The authority emphasized its ongoing commitment to protecting public health, noting that all medicines distributed in Zimbabwe must meet strict standards for safety, quality, and effectiveness.

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