The National Agency for Food and Drugs Administration and Control (NAFDAC) is investigating a case of suspected substandard Deekins Amoxycillin 500mg Capsule manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd, with registration No. 4C639001.
NAFDAC stated Thursday that the investigation stemmed from reports of serious adverse drug reactions being experienced by patients that took the medication across the country.
The agency revealed that the 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.
The director general, NAFDAC, Professor Mojisola Adeyeye, in a statement obtained from Mr. Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH), capsule, Divine King Pharmaceutical Ltd, stated that all products were manufactured by Ecomed Pharma Ltd.
“The manufacturer Ecomed Pharma Ltd claimed to have produced only 20 pockets 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 products have been sampled for laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Mr. Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd.”
She noted that the analysis is currently pending determination while the investigation is ongoing.
Meanwhile, the Quality Control and Production Managers have been invited for further investigation while the Pharmacy Council of Nigeria, the agency that issues site license for the site and the pharmacist in charge has been notified.
