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Public Alert No. 020/2020-Rwanda FDA Recalls Unibrol Antibiotics

October 27, 2020,

The National Agency for Food and Drug Administration and Control has been informed that the Rwandan Food and Drug Authority (FDA) has recalled two batches of Unibrol (Aminosidine Sulphate USP 250mg). This recall was due to the discovery of anomalies in consignments of the drug when conducting different spontaneous assessments on the drug from retail pharmacies. The drugs were found with an issue of colour inconsistency in which some tablets of the same blister were changing colours; some tablets have yellow color while others have white color.

Unibrol is a type of antibiotics used in the treatment of intestinal infections.

Product Details 

The details of the products are as follows;

Product Name: Unibrol (Aminosidine Sulphate USP 250mg)

Product Manufacturer: UNIVERSAL Corporation Ltd based in Kenya

Batch Number: 5806898 and 5806675

NAFDAC implores importers, distributors, retailers, healthcare providers and consumers to exercise caution to avoid the importation, distribution, sale and use of the implicated batches of Unibrol (Aminosidine Sulphate USP 250mg).

Members of the public in possession of the implicated batches are implored to discontinue sale or use and hand over stock to the nearest NAFDAC office.

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of the product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng  

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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