NAFDAC Recalls Deekins Amoxicillin for Life-Threatening Effects

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a recall for one batch of Deekins Amoxicillin 500mg Capsules, which are manufactured by Eco-Med Pharma Ltd and marketed by DevineKings Pharmaceutical Ltd. The affected batch has the lot number 4C639001.

A public alert released on Wednesday indicated that this recall was prompted by reports of serious adverse drug reactions, which could be life-threatening. These reactions may require hospitalization, prolong existing hospital stays, lead to persistent disability or incapacity, result in birth defects, or even cause death in severe cases.

Eco-Med Pharma Ltd reported that a hospital has documented three instances of serious adverse drug reactions among patients who were administered this batch of Deekins Amoxicillin 500mg Capsules.

Amoxicillin is a penicillin antibiotic used to treat various bacterial infections, including tonsillitis, bronchitis, sinusitis, pneumonia, and infections of the ear, nose, throat, skin, or urinary tract.

Product Details:

– Product Name: Deekins Amoxicillin 500mg Capsule
– Marketing Authorization Holder (MAH): DevineKings Pharmaceutical Ltd
– Manufacturer: Eco-Med Pharma Ltd
– Manufacturing Date:** March 2024
– Expiry Date:** February 2027
– Batch No.:** 4C639001

Distributors, healthcare providers, and patients are urged to exercise caution and vigilance within the supply chain to prevent the distribution, administration, and use of the affected lots. All medical products should be sourced from authorized and licensed suppliers, and their authenticity and physical condition should be thoroughly checked.

Anyone in possession of the affected lot is advised to immediately stop selling or using the product and to report their stock to the nearest NAFDAC office. If you or someone you know has used this product and experienced any adverse reactions, it is crucial to seek immediate medical advice from a qualified healthcare professional.

Healthcare professionals and consumers are encouraged to report any suspicions of substandard or counterfeit medicines to the nearest NAFDAC office, or by contacting NAFDAC at 0800-162-3322 or via email at sf.alert@nafdac.gov.ng.

Additionally, healthcare professionals and patients should report any adverse events or side effects related to the use of this medicine either to the nearest NAFDAC office or through the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng. The Med-safety application is also available for download on both Android and iOS stores, along with email reporting options available at pharmacovigilance@nafdac.gov.ng.

Furthermore, please note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).