The National Agency for Food and Drugs Administration and Control (NAFDAC) said it is to commence investigation on a case of suspected substandard Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Limited and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001.
Penpushing reports that a statement by the Marketing Authorization Holder (MAH), Kingsley Ekeanyanwu, explained that the investigation stemmed from reports of serious adverse drug reactions being experienced by patients that took the medication across the country.
The Ecomed Pharma Limited reports of serious adverse drug reactions received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg
Penpushing further reports the statement by the manufacturer Ecomed Pharma Limited claimed to have produced only twenty packets of the affected batch number 4C639001 for the purposes of renewal of his registration.
The statement equally claimed to have manufactured 1,961) packets, Batch No 4C639002, however, 790 packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which said did not manufacture.
Penpushing also reports that the products have been sampled for laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Limited, while analysis is currently pending determination while the investigation which is ongoing.
The Quality Control and Production Managers have, been invited for further investigation, while the Pharmacy Council of Nigeria, the Agency that issue site license for the site and the Pharmacist in charge has been notified.
‘The public is hereby warned to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule. 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’
Penpushing reports that National Agency for Food and Drugs Administration and Control (NAFDAC) declared that all medical products must be obtained from authorized/licensed suppliers, emphasizing that 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’, the statement stated.
‘An alert has been placed against this product on December 3, 2024 https://nafdac.gov.ng/public-alert-no-048-2024-alert-on-recall-of-deekins-amoxycillin-500mg-capsule-batch-4c639001/ . 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)’.
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