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.
Risk
An adverse reaction to drugs may be life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, or is a birth defect or death in fatal cases.
Product Details
The details of the affected product are as follows.
Product Name | MAH | Product Manufacturer | Manufacturing Date | Expiry Date | Batch No. |
Deekins Amoxycillin 500mg Capsule | Kings Pharmaceutical Ltd | Ecomed Pharma Ltd. | 03/2024 | 02/2027 | 4C639001 |
Please, see the picture below.
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 consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, 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.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!