From Fred Ezeh, Abuja
National Agency for Food and Drugs Administration and Control (NAFDAC) has confirmed that a substandard Amoxycillin 500mg Capsule with a brand name Deekins is in circulation across the country.
The Agency said that the quality and genuineness of the product which was manufactured by Ecomed Pharma Ltd, and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001, became suspicious when some serious cases of adverse drug reactions were reported.
NAFDAC Director General, Dr. Mojisola Adeyeye, told journalists at a press conference, in Abuja, that the Agency became more furious when a hospital reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg
She said that during preliminary investigation, Mr. Kingsley Ekeanyanwu of the Divine King Pharmaceutical Ltd, the Marketing Authorization Holder (MAH) of the product stated that all products were manufactured by Ecomed Pharma Ltd.
The manufacturer, Ekene Christopher, of the Ecomed Pharma Ltd, in his statement claimed to have produced only 20 of the affected batch number 4C639001 for the purposes of renewal of his registration.
He also claimed to have manufactured 1,961 packets with batch No 4C639002. However, 790 packs of batch 4C639001 with manufacturing date 03/2024 and expiry date 02/2027 were recalled, which he did not manufacture.
The NAFDAC boss said the products have been sampled for further laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Mr. Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd, stressing that the analysis is currently pending determination while the investigation which is ongoing.
“Meanwhile, the Quality Control and Production Managers have been invited for further investigation, while the Pharmacy Council of Nigeria (PCN), the Agency that issue site license for the site and the Pharmacist in charge has been notified,” said Prof. Adeyeye.
She asked Nigerians to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule, appealing to distributors, healthcare providers, and patients to exercise caution and vigilance within the drugs supply chain to avoid distribution, administration, and use of the affected lots of the product.
She insisted that all medical products must be obtained from authorized/licensed suppliers, suggesting that products’ authenticity and physical condition should be carefully checked.
She asked anyone in possession of the affected lot to immediately discontinue the sale or use, and submit the stock to the nearest NAFDAC office.
“But if you have used this product, or someone you know, has used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional,” she suggested.