The National Agency for Food and Drug Administration and Control (NAFDAC) has initiated an investigation into reports of serious adverse reactions linked to Deekins Amoxycillin 500mg capsules.
The medication, allegedly produced by Ecomed Pharma Ltd and marketed by Divine Kings Pharmaceutical Ltd, is suspected to be substandard, particularly batch number 4C639001.
The fake medicine, bearing a manufacturing date of March 2024 and an expiry date of February 2027, has since been recalled by the agency while warning caregivers and the public to be cautious and vigilant of the drug and alert the agency should they come across it while seeking care.
The Director General of NAFDAC, Prof. Mojisola Adeyeye disclosed in Abuja on Thursday at a press briefing, where she emphasized that the issue would be escalated to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) as the drug might have found its ways across the Nigerian borders.
This step, she said ensures that international stakeholders are informed of the risks posed by the counterfeit medication.
Detailing how a hospital documented three cases of severe adverse reactions associated with the batch, which prompted the investigation and the eventual recall of their drug, she said, “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.
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“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 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. Related News
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“The analysis is currently pending determination while the investigation is ongoing.
“Meanwhile, the Quality Control and Production Managers have been invited for further investigation.
“The Pharmacy Council of Nigeria, the Agency that issues site licenses for the site and the Pharmacist in charge has been notified.
While assuring that the agency has several Prevent, Detect and Respond mechanisms, including WHO-certified methods to prevent fake, falsified and substandard medicines from flooding the market, Adeyeye cautioned consumers to avoid using the suspected batch of Deekins Amoxycillin 500mg capsules.
She said it was due to its vigilance that the agency operatives were able to detect a children’s medicine that contained zero content in Kano.
Describing the industry players that engage in falsified, fake and substandard drugs as murderers, the DG said the suspected perpetrators have been apprehended and are in court.
She, however, urged distributors and healthcare providers to check the authenticity of all medical products and ensure they are sourced from licensed suppliers.
While emphasizing the importance of vigilance within the supply chain to prevent the distribution and administration of counterfeit drugs, the DG called on anyone in possession of the affected batch to cease its use immediately and submit any remaining stock to the nearest NAFDAC office.
She also advised patients who have used the product and experienced adverse effects to seek medical attention promptly.
The DG reiterated NAFDAC’s commitment to safeguarding public health while urging all stakeholders to remain vigilant in reporting and addressing incidents of substandard and falsified medicine.
