The National Agency for Food and Drug Administration and Control (NAFDAC) has commenced an investigation into reports of three serious adverse drug reactions linked to a batch of Deekins Amoxicillin 500mg capsules.
The affected batch, identified as 4C639001, was manufactured by Eco-med Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd. Following the reports, the agency ordered an immediate recall of the batch.
The investigation began after a hospital reported severe adverse reactions from patients administered the affected capsules. Amoxicillin, a widely used penicillin antibiotic, is typically prescribed to treat bacterial infections. However, adverse reactions can lead to severe health complications, including hospitalization, disability, and even death in extreme cases.
According to Mr. Kingsley Ekeanyanwu, the Marketing Authorization Holder of Devine Kings Pharmaceutical Ltd, all products under investigation were produced by Eco-med Pharma Ltd. However, Eco-med Pharma claimed that only 20 packets of the affected batch were manufactured for registration renewal purposes. The company denied producing an additional 790 packs with a manufacturing date of March 2024 and an expiry date of February 2027, which have now been recalled.
NAFDAC has sent samples of the suspected products for laboratory analysis and invited Eco-med Pharma’s Quality Control and Production Managers for questioning. The Pharmacy Council of Nigeria and the pharmacist in charge of the batch have also been notified. While awaiting the test results, NAFDAC has urged the public to avoid the affected Deekins Amoxicillin capsules and to ensure all medical products are purchased from authorized suppliers.
The agency advised anyone in possession of the affected batch to discontinue use immediately and report to the nearest NAFDAC office. It also called on patients and healthcare providers to report any adverse reactions promptly via its official contact channels, including an email to sf.alert@nafdac.gov.ng. This precaution, NAFDAC stressed, is vital in ensuring public safety and the integrity of medical products in circulation.