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Rwanda FDA recalls batches of Unibrol

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The Rwanda Food and Drugs Authority (FDA) has temporarily recalled two batches of Unibrol (Aminosidine Sulphate USP 250mg) after the discovery of anomalies in consignments of the drug,

This is according to a senior official on Monday, 28 September 2020.

Unibrol is a type of antibiotics used in the treatment of intestinal infections. The food and drugs regulator said that the decision was taken after conducting different spontaneous assessments on the drug from retail pharmacies and preliminary findings.

According to a notice signed by the acting Director-General of the Authority, Dr Charles Karangwa, drugs from the concerned batches are to be taken off the shelves and stored, pending an outcome of a full investigation.

The concerned batches are: 5806898 and 5806675, both manufactured by UNIVERSAL Corporation Ltd in Kenya.

“We found these medicines with an issue of changing colour for some tablets of the same blister; some tablets have a yellow colour, while others have a white colour. It is in that regard that the following batches are called for quarantine while the Authority is conducting further investigation,” read the announcement.

The whole concerned value chain of the drug has been ordered to quarantine it.

“Rwanda Food and Drugs Authority instructs all importers, central medical stores, wholesalers, district pharmacies, retailers, public and private health facilities in possession of the mentioned batches of Unibrol (Aminosidine Sulphate USP 250mg) to quarantine all quantities in their stores until the investigation is concluded,” the statement added.



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