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From Fred Ezeh, Abuja
The National Agency for Food and Drugs Administration and Control (NAFDAC) has confirmed that a substandard Amoxycillin 500mg capsule with the brand name Deekins is in circulation across the country.
The Agency stated that the quality and genuineness of the product, manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd with lot number 4C639001, became suspicious following reports of serious adverse drug reactions.
NAFDAC Director General, Dr Mojisola Adeyeye, told journalists at a press conference in Abuja on Thursday that the Agency became more alarmed after a hospital reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg.
She explained that during preliminary investigations, Mr Kingsley Ekeanyanwu of Devine Kings Pharmaceutical Ltd, the Marketing Authorisation Holder (MAH) of the product, stated that all products were manufactured by Ecomed Pharma Ltd.
The manufacturer, Ekene Christopher of Ecomed Pharma Ltd, claimed in his statement that he had produced only 20 packets of the affected batch number 4C639001 for the purpose of renewing his registration.
He further claimed to have manufactured 1,961 packets with batch number 4C639002. However, 790 packs of batch 4C639001, with a manufacturing date of 03/2024 and an expiry date of 02/2027, were recalled—a quantity he denied manufacturing.
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The NAFDAC boss disclosed that the products have been sampled for further laboratory analysis. She added that suspects, including Pharm. Ekene Christopher of Ecomed Pharma Ltd and Mr Kingsley Ekeanyanwu of Devine Kings Pharmaceutical Ltd, are under investigation, with the analysis currently pending determination.
“Meanwhile, the Quality Control and Production Managers have been invited for further investigation, while the Pharmacy Council of Nigeria (PCN), the agency that issues site licences, and the pharmacist in charge have been notified,” said Prof. Adeyeye.
She urged 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 drug supply chain to prevent the distribution, administration, and use of the affected lots.
Prof. Adeyeye insisted that all medical products must be obtained from authorised/licensed suppliers and advised that the authenticity and physical condition of products should always be carefully checked.
She instructed anyone in possession of the affected lot to immediately discontinue its sale or use and to 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 said.
