Rwanda recalls India-made Amoxicillin, Metronidazole

Photo of the recalled Amoxicillin 125mg/5ml (SPAMOX).

Rwanda Food and Drugs Authority (FDA) has alerted drug importers, medical stores, pharmacies, retailers and health establishments in the country to stop distribution of Amoxicillin 125mg/5ml (SPAMOX) and Metronidazole Vaginal Tablet 500mg.

At least nine batches of the drugs, used to treat infections, failed quality control tests and have therefore been recalled from the Rwandan market. Details indicate that recalled drugs are made in India.

FDA requires those holding the recalled medicines to return them to the suppliers for suitable management.

“The importers and suppliers of the recalled medicines are requested to report to Rwanda FDA within 10 working days the quantities imported, quantities distributed, quantities returned and final stock on hand,” FDA said in a note sent to health facilities, medical stores, pharmacies and drug importers nationwide.


Spamox Amoxicillin is made by India-based Sparsh BioTech Pvt. Ltd, a pharmaceutical manufacturer and exporter, while Metronidazole is manufactured by Agog Ltd.

The recall is understood to be issued following deep investigation and laboratory quality control tests performed by Rwanda FDA on reported poor quality of the products.

Test results confirmed the reported medicines are of poor quality, the agency said in a statement issued Wednesday.

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