The National Agency for Food and Drugs Administration and Control (NAFDAC) said it has begun an investigation into the case of suspected substandard Deekins Amoxycillin 500mg Capsule, manufactured by Eco-med Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001.
This investigation stemmed from reports of serious adverse drug reactions being experienced by patients who took the medication across the country.
NAFDAC notified the public last week of the recall of one batch of Deekins Amoxycillin 500mg Capsule following reports of serious adverse drug reactions.
According to Eco-med 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
Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH) and Devine King Pharmaceutical Ltd stated that Eco-med Pharma Ltd manufactured the products.
The manufacturer, Eco-med Pharma Ltd claimed to have produced only twenty packets (20) of the affected batch number 4C639001 for renewal of his registration. He also claimed to have manufactured 1,961 packets, Batch No 4C639002 and noted that 790 packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which he did not manufacture.
NAFDAC said the products have been sampled for laboratory analysis against the suspects, Pharm Ekene Christopher of Eco-med Pharma Ltd and Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd, the analysis is currently pending while the investigation is ongoing.
The Food and Drug Agency said that in the meantime, the Quality Control and Production Managers have been invited for further investigation while the Pharmacy Council of Nigeria (PCN) that issued the site license and the Pharmacist in charge have been notified.
It thereby warns the public to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule
NAFDAC also implored distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid the affected lots of the product. It warned that all products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
It also implored anyone in possession of the affected lot 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.
