The National Agency for Food and Drug Administration and Control (NAFDAC) has launched an investigation into a batch of suspected substandard Deekins Amoxicillin 500mg capsules after reports of three serious adverse drug reactions.
The affected batch, identified as 4C639001, was manufactured by Eco-med Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd.
Following the reports of adverse reactions, the batch has been recalled.
“The investigation was prompted from reports of serious adverse drug reactions received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg,” said NAFDAC.
Amoxicillin, a penicillin antibiotic, is commonly used to treat various bacterial infections, but adverse reactions can be severe, potentially leading to hospitalization, disability, birth defects, or even death.
Manufacturer claims limited production
Mr. Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH) of Divine King Pharmaceutical Ltd, disclosed that all products under investigation were manufactured by Ecomed Pharma Ltd.
Ecomed Pharma Ltd claimed in its statement that it produced only 20 packets of the affected batch number 4C639001 solely for registration renewal purposes.
The company further stated that it manufactured 1,961 packets under batch number 4C639002. However, it denied manufacturing 790 packs of batch 4C639001, with a manufacturing date of 03/2024 and an expiry date of 02/2027, which had been recalled.
Ongoing investigation and public safety alert
NAFDAC has sent the suspected products for laboratory analysis, focusing on the involvement of Pharm. Ekene Christopher, Ecomed Pharma Ltd, and Mr. Kingsley Ekeanyanwu of Devine Kings Pharmaceutical Ltd.
- The analysis results are still pending as the investigation continues.
- The agency has invited the Quality Control and Production Managers for further questioning, while the Pharmacy Council of Nigeria and the pharmacist in charge have been notified.
In the meantime, NAFDAC has issued a public warning, urging the public to avoid using the suspected substandard Deekins Amoxicillin 500mg capsules. It also advises distributors, healthcare providers, and patients to exercise caution in the supply chain to prevent the distribution or use of the affected batches.
Important safety measures
NAFDAC urges all medical products to be obtained from authorized, licensed suppliers and for consumers to carefully inspect the authenticity and condition of any products. Anyone in possession of the affected batch should immediately discontinue use or sale and submit the stock to the nearest NAFDAC office.
If anyone has used this product or experienced any adverse reactions, they are advised to seek medical attention promptly and report the incident to NAFDAC via their office, phone, or email: sf.alert@nafdac.gov.ng.