The Director General of the National Agency for Food and Drugs Administration and Control (NAFDAC), Professor Mojisola Adeyeye, revealed on Thursday that Kingsley Ekeanyanwu, the Managing Director of Divine Kings Pharmaceutical Limited, is currently in police custody in connection with the suspected substandard Deekins Amoxycillin 500mg capsules.
Speaking at a press briefing in Abuja, Adeyeye confirmed that NAFDAC is actively investigating the suspected substandard batch of Deekins Amoxycillin, which was manufactured by Ecomed Pharma Ltd. The investigation follows numerous reports of serious adverse drug reactions experienced by patients who took the medication across the country.
“If we see bad actors, we go after them, we shut them down. We inspect their facilities. If they don’t meet Good Manufacturing Practices, we shut them down temporarily or permanently, depending on the severity; we have done that, and we have records,” Adeyeye explained.
The NAFDAC boss further stated that the recall of the product had been initiated on Wednesday following reports of serious adverse drug reactions linked to a specific batch. “According to Ecomed Pharma Ltd, reports of adverse reactions were received from a hospital that reported three cases from patients administered with the batch of Deekins Amoxycillin 500mg,” she added.
In a statement provided by Ekeanyanwu, the Marketing Authorization Holder of Divine Kings Pharmaceutical Ltd, the company claimed that all the products were manufactured by Ecomed Pharma Ltd. However, the manufacturer of the capsules, Ecomed Pharma Ltd, clarified that only 20 packets of the affected batch (number 4C639001) were produced for registration renewal purposes, and another batch (4C639002) of 1,961 packets was also manufactured. Ecomed Pharma further stated that 790 packs from Batch 4C639001 were recalled due to discrepancies in production, as these were not part of their manufacturing process.
The Director General disclosed that the affected products have been sampled for laboratory analysis and that investigations are ongoing. Additionally, the Quality Control and Production Managers involved have been invited for further questioning. Relevant authorities, including the Pharmacy Council of Nigeria, have been notified of the ongoing investigation.
“The public is hereby warned to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule,” Adeyeye emphasised. “NAFDAC implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to prevent the distribution, administration, and use of the affected lots. All medical products must be obtained from authorised/licensed suppliers, and their authenticity and physical condition should be carefully checked.”
NAFDAC also urged anyone in possession of the affected batch to immediately discontinue use or sale of the product and to submit any remaining stock to the nearest NAFDAC office. Consumers who have used the product or experienced any adverse reactions are advised to seek medical attention and report the issue to NAFDAC.
An official alert regarding the product was issued on 3rd December 2024, with NAFDAC encouraging healthcare professionals and the public to report any suspicions of substandard or falsified medicines. The agency has provided contact details for reporting, including a dedicated phone line and email, as well as a Med-safety application for mobile reporting.
This notice will also be shared on the World Health Organisation’s Global Surveillance and Monitoring System.
