The National Agency for Food and Drug Administration and Control (NAFDAC) has initiated an investigation into a suspect batch of Deekins Amoxicillin 500mg capsules. This move follows reports of three serious adverse drug reactions linked to the batch, identified as 4C639001.
The batch in question was manufactured by Eco-med Pharma Ltd and distributed by Devine Kings Pharmaceutical Ltd. In response to the adverse reaction reports, NAFDAC has issued a recall of the affected batch.Amoxicillin, a widely used antibiotic, is prescribed to treat various bacterial infections. However, it can cause severe adverse reactions, potentially resulting in hospitalization, disability, birth defects, or even death.
“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. NAFDAC’s investigation aims to determine the cause of the adverse reactions and ensure the safety and quality of the medication. The agency’s prompt response underscores its commitment to protecting public health and safety.
Kingsley Ekeanyanwu, the Marketing Authorization Holder (MAH) of Divine King Pharmaceutical Ltd, revealed that the products under investigation were manufactured by Ecomed Pharma Ltd.In a statement, Ecomed Pharma Ltd clarified that it produced only 20 packets of the affected batch number 4C639001, specifically for registration renewal purposes. The company also confirmed manufacturing 1,961 packets under batch number 4C639002.
However, Ecomed Pharma Ltd denied producing 790 packs of batch 4C639001, with a manufacturing date of March 2024 and an expiry date of February 2027. This batch had been recalled due to concerns over its safety and quality.
INVESTIGATION AND PUBLIC SAFETY AWARENESS
NAFDAC has taken swift action in response to reports of adverse reactions to Deekins Amoxicillin 500mg capsules. The agency has sent the suspected products for laboratory analysis, focusing on the roles of Pharm. Ekene Christopher, Ecomed Pharma Ltd, and Mr. Kingsley Ekeanyanwu of Devine Kings Pharmaceutical Ltd.
As the investigation unfolds, NAFDAC has invited the Quality Control and Production Managers for further questioning. The Pharmacy Council of Nigeria and the pharmacist in charge have also been notified. To ensure public safety, NAFDAC has issued a public warning, advising the public to avoid using the suspected substandard Deekins Amoxicillin 500mg capsules. Distributors, healthcare providers, and patients are also cautioned to exercise vigilance in the supply chain to prevent the distribution or use of the affected batches.
SAFETY MEASURE
sNAFDAC is advising the public to exercise caution when purchasing medical products. To ensure safety, consumers should only obtain products from authorized, licensed suppliers. Additionally, it is crucial to carefully inspect the authenticity and condition of any products before use.If you are in possession of the affected batch of Deekins Amoxicillin 500mg capsules, please discontinue use or sale immediately. Return the stock to the nearest NAFDAC office for proper handling. If you have used this product and experienced any adverse reactions, seek medical attention promptly. Report the incident to NAFDAC through their office, phone, or email at sf.alert@nafdac.gov.ng
Source: https://nairametrics.com
