National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted Nigerians of the recall of one batch of Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001.
In a statement released, the agency says the 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,” the statement read.
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.
NAFDAC explained that adverse reactions to drugs may be life-threatening, and may require hospitalisation or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, or is a birth defect or death in fatal cases. The product details of the affected product are as follows: Name: MAH manufactured by Ecomed Pharmaceutical Ltd. Date of manufacturing: 03/2024, Expiry date: 02/2027, and batch number: 4C639001.
The Agency further implored 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 consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: [email protected],” the statement read in part.
NAFDAC further encouraged healthcare professionals and patients 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.
