FDA suspends Unibrol drugs in Rwanda

By Elina Jonas Ruzindaza
On 29 September 2020 at 03:04

Food and Drugs Authority (FDA) has announced that the Unibrol drugs (Aminosidine Sulphate USP 250mg) are to be taken off the Rwandan market pending an outcome of a full investigation.

A statement from the FDA said, “There are pills that have changed color, so full investigation must take place to know its cause so that it will not harm the users.”

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

The drugs are Unibrol / Aminosidine Sulphate USP 250mg, number 5806898, manufactured in September 2019, will expire in August 2022. Another is Unibrol/Aminosidine Sulphate USP 250mg with number 5806675, made in June 2019, and will expire on May 2022.

Both drugs were manufactured by UNIVERSAL Corporation Ltd, based in Kenya. The FDA has asked everyone affected by the decision, as well as Rwandans in general, to stop using the above-mentioned drugs.

“Rwanda FDA instructs all importers, central medical stores, wholesalers, district pharmacies, retailers, public and private health facilities in possession of the mentioned drugs to stop distributing and giving the patients until the investigation is concluded,” the announcement adds.

Unibrol drugs (Aminosidine Sulphate USP 250mg) are to be taken off the Rwandan market pending an outcome of a full investigation

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