The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned the public to avoid the use of Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd adding that investigation was ongoing to unravel the cases of serious adverse drug reactions from patients.
This was contained in a statement issued by the agency on Thursday.
NAFDAC explained 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 Amoxycillin 500mg.
“In the 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 in his statement claimed to have produced only twenty packets (20) of the affected batch number 4C639001 for the purposes of renewal of his registration. He also claimed to have manufactured One Thousand, Nine Hundred and Sixty-One (1,961) packets, Batch No 4C639002. However, Seven Hundred and Ninety (790) packs of Batch 4C639001 with manufacturing 03/2024 and Expiry Date 02/2027 were recalled, which he did not manufacture”.
The Agency informed that the products had been “sampled for laboratory analysis against the suspects, Pharm Ekene Christopher, Ecomed Pharma Ltd and Mr. Kingsley Ekeanyanwu, of Devine Kings Pharmaceutical Ltd. The analysis is currently pending determination while the investigation which is ongoing.
“Meanwhile, the Quality Control and Production Managers have been invited for further investigation, The Pharmacy Council of Nigeria, the Agency that issue site license for the site and the Pharmacist in charge has been notified”.
NAFDAC therefore, warned the public to avoid the use of the suspected substandard Deekins Amoxycillin 500mg Capsule.
The Agency also implored distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the affected lots of the product.
“All medical products must be obtained from authorized/licensed suppliers. The products authenticity and physical condition should be carefully checked.
“Anyone in possession of the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office”, the statement concluded.
