The National Agency for Food and Drugs Administration and Control (NAFDAC) says the marketer of the suspected substandard Deekins Amoxycillin 500mg capsule, Mr Kingsley Ekeanyanwu, has been arrested by the Nigeria Police Force, as the regulatory agency commences investigation into the case.
NAFDAC Director General, Prof. Moji Adeyeye, made the disclosure to journalists on Thursday, noting that the investigation stemmed from reports of serious adverse drug reactions experienced by patients that took the medication across the country.
In an exclusive interview with Pharmanewsonline on Thursday, the contract-manufacturer of the recalled Deekins Amoxycillin 500mg capsule, Pharm. Ekene Christopher, claimed the marketer of the product cloned the affected packs, saying only twenty packs (20) of the affected batch number 4C639001 were produced on contract for the purpose of renewal of his registration.
He said, “We want to reiterate here that the “Deekins Amoxycillin ” with batch number 4C639001 in circulation was not produced by Ecomed Pharma Ltd. It is a fake product cloned by Divine Kings Pharma with our name on it.”
Pharm. Christopher, according to his statement from NAFDAC, disclosed to have manufactured one thousand, nine hundred and sixty-one (1,961) packets, with batch no 4C639002. “However, seven hundred and ninety (790) packs of batch no 4C639001 with manufacturing 03/2024 and expiry Date 02/2027 were recalled, which he did not manufacture.”
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, upon which the pharma company alerted NAFDAC officials on the development.
Conversely, CEO of Divine King Pharmaceutical Ltd, Mr Kingsley Ekeanyanwu, the Marketing Authorisation Holder (MAH), of Deekins Amoxycillin 500mg capsule, in a statement obtained by NAFDAC revealed that all products were manufactured by Ecomed Pharma Ltd.
The NAFDAC DG affirmed that investigation is ongoing to get to the root of the matter, as products have been sampled for laboratory analysis against the two parties, Pharm. Christopher and Mr Ekeanyanwu, The analysis is currently pending determination while the investigation which is ongoing, she stated.
According to Adeyeye, “the Quality Control and Production Managers have been invited for further investigation. The Pharmacy Council of Nigeria, the agency that issue site licence for the site and the Pharmacist in charge have been notified.
“The public is hereby warned to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule,” she reiterated.
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