The National Agency for Food Drugs Administration and Control (NAFDAC) has confirmed the arrest of the Managing Director of Divine Kings Pharmaceutical Limited, Kingsley Ekeanyanwu for marketing the substandard Deekins Amoxicillin 500mg capsules.
This was confirmed by the Director General (DG) of the agency, Professor Mojisola Adeyeye, on Thursday, December 12.
Adeyeye stated that NAFDAC is currently investigating the Deekins capsules, which are produced by Ecomed Pharma Ltd.
The investigation was initiated following reports of severe adverse drug reactions from patients who used the medication nationwide.
She said, “If we see bad actors, we go after them, we shut them down.
“We inspect their facility. If they don’t meet Good Manufacturing Practices, we shut them down temporarily or permanently, depending on the gravity; we have done that, and we have record.”
The NAFDAC director also revealed that the product had been recalled following the reports of adverse reactions.
Adding that, “According to Ecomed 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 Amoxicillin 500mg.”
In a statement from Ekeanyanwu, the marketing authorization holder, Divine Kings Pharmaceutical Ltd, stated that all products were produced by Ecomed Pharma Ltd.
However, Adeyeye clarified that inconsistencies had arisen.
The NAFDAC DG further stated that, “The manufacturer Ecomed Pharma Ltd in his statement claimed to have produced only 20 packets of the affected batch number 4C639001 for the purposes of renewal of his registration.
“He also claimed to have manufactured 1,961 packets, Batch No 4C639002.
“However, 790 packs of Batch 4C639001 with manufacturing 03/2024 and expiry date 02/2027 were recalled, which he did not manufacture.”
The affected products have been sent for laboratory testing, and further investigations are focusing on the suspects, Pharm Ekene Christopher from Ecomed Pharma Ltd, and Ekeanyanwu of Divine Kings Pharmaceutical Ltd.
In the meantime, the Quality Control and Production Managers have been called in for questioning.
The Pharmacy Council of Nigeria (PCN) has also been informed.
NAFDAC has issued a public advisory urging people to avoid using the Deekins Amoxicillin 500mg capsules.
Adeyeye called on distributors, healthcare providers and patients to stay alert and verify the authenticity and condition of medical products.
“Anyone in possession of the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office,” she concluded.
The public has been urged to report any adverse reactions or concerns about substandard products.
The alert for the affected batch was issued on Tuesday, December 3, 2024.
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