Posted by Samuel on Thu 12th Dec, 2024 - tori.ng
The arrest was confirmed by the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, during a press briefing in Abuja on Thursday.
Kingsley Ekeanyanwu, the Managing Director of Divine Kings Pharmaceutical Limited, has been arrested in connection with the suspended Deekins Amoxicillin 500mg capsule, suspected to be substandard.
The arrest was confirmed by the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, during a press briefing in Abuja on Thursday.
Adeyeye disclosed that NAFDAC is investigating the substandard Deekins capsules, which are manufactured by Ecomed Pharma Ltd.
The investigation was prompted by reports of serious adverse drug reactions from patients who used the medication across the country.
“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,” Adeyeye said.
The NAFDAC boss further revealed that the product had been recalled after the adverse reactions were reported.
“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 Amoxycillin 500mg,” she explained.
In a statement obtained from Ekeanyanwu, the marketing authorisation holder, Divine Kings Pharmaceutical Ltd, had claimed that all products were manufactured by Ecomed Pharma Ltd. However, Adeyeye clarified that discrepancies had emerged.
“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,” she stated.
The affected products have been sent for laboratory analysis, with further investigations focusing on the suspects, Pharm Ekene Christopher from Ecomed Pharma Ltd, and Mr. Ekeanyanwu of Divine Kings Pharmaceutical Ltd.
Meanwhile, the Quality Control and Production Managers have been invited for questioning. The Pharmacy Council of Nigeria has also been notified.
NAFDAC has issued a public warning to avoid using the Deekins Amoxycillin 500mg capsule. Adeyeye urged distributors, healthcare providers, and patients to remain vigilant and check 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 added.
The public has also been encouraged to report any adverse reactions or suspicions of substandard products. The alert for the affected batch was issued on December 3, 2024.