During a press briefing in Abuja, Adeyeye revealed that the agency is actively investigating the Deekins capsules, which are manufactured by Ecomed Pharma Ltd.
"We take action against any bad actors we identify; we shut them down and conduct inspections of their facilities. If they fail to comply with Good Manufacturing Practices, we may temporarily or permanently close them, depending on the severity of the violations. We have a record of such actions," she stated.
In this specific case, she confirmed that the Managing Director of Divine Kings Pharmaceutical is being held in Lagos.
Adeyeye highlighted that the investigation was prompted by reports of serious adverse drug reactions experienced by patients who had taken the medication nationwide.
On Wednesday, NAFDAC announced the recall of the drug due to these concerning reports.
"The reports of serious adverse drug reactions were initially received from a hospital that documented three cases linked to the batch of Deekins Amoxycillin 500mg," Adeyeye explained.
She also noted that according to a statement from Kingsley Ekeanyanwu, the Marketing Authorization Holder, all products were manufactured by Ecomed Pharma Ltd.
Ecomed Pharma Ltd has stated that it produced only 20 packets of the affected batch number 4C639001 for the purpose of renewing its registration. Additionally, the company reported manufacturing 1,961 packets of Batch No 4C639002. However, it was noted that 790 packs of Batch 4C639001, with a manufacturing date of 03/2024 and an expiry date of 02/2027, were recalled, despite not being produced by the manufacturer, according to Adeyeye.
She mentioned that samples of the products have been collected for laboratory analysis concerning the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd, and Mr. Kingsley Ekeanyanwu of Devine Kings Pharmaceutical Ltd.
The analysis is currently pending, and the investigation is ongoing.
In the meantime, the Quality Control and Production Managers have been summoned for further inquiry. The Pharmacy Council of Nigeria, which issues site licenses, and the responsible pharmacist have been informed.
The public is advised to refrain from using the suspected substandard Deekins Amoxycillin 500mg Capsule. NAFDAC urges distributors, healthcare providers, and patients to remain cautious and vigilant throughout the supply chain to prevent the distribution, administration, and use of the affected product lots. It is essential to procure all medical products from authorized and licensed suppliers, ensuring the authenticity and physical condition of the products are thoroughly checked.
Individuals in possession of the affected lot are urged to cease sales or use immediately and to return the stock to the nearest NAFDAC office. If anyone has used this product or knows someone who has experienced any adverse reactions after use, they should seek immediate medical advice from a qualified healthcare professional. An alert regarding this product was issued on December 3, 2024.
Healthcare professionals and consumers are urged to report any concerns regarding substandard or counterfeit medicines to the nearest NAFDAC office, by calling NAFDAC at 0800-162-3322, or via email at sf.alert@nafdac.gov.ng.
In addition, healthcare providers and patients are encouraged to report any adverse events or side effects associated with medicinal products to the nearest NAFDAC office. Reports can also be submitted through the E-reporting platforms available on the NAFDAC website at www.nafdac.gov.ng, via the Med-safety application downloadable on Android and iOS, or by emailing pharmacovigilance@nafdac.gov.ng.
Moreover, it is important to note that this notice will be shared with the WHO Global Surveillance and Monitoring System, she stated.