The National Agency for Food and Drugs Administration and Control (NAFDAC) has disclosed that it is investigating a case of suspected substandard Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001 now in the drugs market
The agency indicated that its investigation stemmed from reports Ecomed Pharma Ltd of the serious adverse drug reactions being experienced by patients that were administered with the Deekins Amoxycillin 500mg capsule based on doctors’ prescription in the country.
In the statement obtained from Mr. Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH), disclosed that the capsule were manufactured by Ecomed Pharma Ltd.
However, in its reaction Ecomed Pharma Ltd claimed to have produced only twenty packets (20) of the affected batch number 4C639001 for the purposes of renewal of its registration.
The company claimed to have manufactured 1,961 packets, Batch No 4C639002 whereas 790 packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which it claimed it did not manufacture.
According to the NAFDAC’s Director-General, the products have been sampled for laboratory analysis against the suspects, Pharmacist Ekene Christopher, Ecomed Pharma Ltd, and Mr. Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd while the investigation remains on-going.
Adeyeye confirmed that the Quality Control and Production Managers of the companies had been invited for further investigation and that Pharmacists Council of Nigeria (PCN) had been notified about the agency’s on-going investigation.
She warned members of the public to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule
This is even as the agency 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, adding that all medical products must be obtained from authorized/licensed suppliers and products’ authenticity and physical condition should be carefully checked.
The Director-General advised anyone in possession of the affected lot to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office, stressing that “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.”
Adeyeye confirmed that an alert had been placed against the product on December 3, 2024 and urged healthcare professionals and consumers 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, she 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 or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
