A batch of Deekins Amoxycillin 500 mg capsules has been recalled by the National Agency for Food and Drug Administration and Control (NAFDAC).
The agency made the announcement on Wednesday in a statement shared on X (formerly Twitter), noting that the affected batch, with lot number 4C639001, was manufactured by Eco-med Pharma Ltd and marketed by DevineKings Pharmaceutical Ltd.
NAFDAC explained that the recall followed reports of serious adverse drug reactions associated with this batch.
According to Eco-med Pharma Ltd, a hospital reported three cases of severe reactions in patients who were administered capsules from this batch.
“The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of one batch of Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by DevineKings Pharmaceutical Ltd, with lot number 4C639001. This drug batch is being recalled following reports of serious adverse drug reactions.
“According to Ecomed Pharma Ltd, reports of serious adverse drug reactions were received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg capsule.
“Amoxicillin is a penicillin antibiotic indicated for treating bacterial infections such as tonsillitis, bronchitis, sinusitis, pneumonia, and bacterial infections of the ear, nose, throat, skin, or urinary tract.
“An adverse reaction to drugs may be life-threatening, may require hospitalization or prolongation of existing hospitalisation, result in persistent or significant disability or incapacity, or is a birth defect or death in fatal cases.
“NAFDAC implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the affected lots of the product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Anyone in possession of the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you have used this product, or someone you know, has used it, or suffered any adverse reaction/event after use, are advised to seek immediate medical advice from a qualified healthcare professional.
“Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.
“Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).”
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