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ZAMRA Addresses Quality Concerns Over Erythromycin Tablets in Health Centre Kits

The Zambia Medicines Regulatory Authority (ZAMRA) has issued a press statement addressing recent concerns surrounding specific batches of Erythromycin Stearate 250mg Tablets BP, which are part of the Health Centre Kits supplied by Mission Pharma.

In the statement delivered by Ludovic Mwape, ZAMRA’s Senior Public Relations Officer, the authority clarified that the antibiotic in question is included in the Health Centre Kit (HCK) supplied by Mission Pharma, Denmark. 

These kits are imported by the Zambia Medicines and Medical Supplies Agency (ZAMMSA), a procurement entity of the Ministry of Health.

Mr. Mwape explained that the Health Centre Kit is a combination of medicines and allied substances from various manufacturers, assembled for distribution to health facilities. 

ZAMMSA has imported three consignments of these kits at different timeframes, with ZAMRA conducting pre-distribution sampling and testing to ensure product quality before distribution to health centers.

He highlighted that the first and second consignments underwent rigorous testing, and all products, including Erythromycin Stearate 250mg BP Tablets, met the required standards. 

However, he acknowledged that products from the third shipment were found to have some batches of Erythromycin Stearate 250mg BP Tablets that did not conform to the quality standard of dissolution.

Following standard procedures, ZAMRA advised ZAMMSA to secure the affected product for disposal or return to the supplier. 

Mr. Mwape reassured the public that none of the affected batches had been distributed by ZAMMSA, emphasizing that there is no cause for alarm.

He further emphasized that such occurrences are not uncommon in the global pharmaceutical manufacturing industry. 

Regulatory bodies, like ZAMRA, he said are established to promptly address and rectify such situations, ensuring public safety.

Mr. Mwape concluded by reiterating ZAMRA’s commitment to upholding the highest standards of quality, safety, and efficacy in medicines and allied substances available in Zambia.

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