National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers and the public to the voluntary recall of a batch of Sporidex Suspension 125 mg/5 mL after an impurity exceeding the approved specification limit was detected.
Gatekeepers News reports that the affected product is Batch No. DFG4606A, manufactured by Ranbaxy Nigeria Ltd., a Sun Pharma company.
NAFDAC said the impurity could compromise the medicine’s quality, safety and stability. Sporidex Suspension, which contains cephalexin, is commonly prescribed for children to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary bladder and kidneys.
The agency warned that using the affected batch may reduce the effectiveness of the antibiotic, leading to incomplete elimination of bacteria, delayed recovery, worsening infections or treatment failure.
It also noted that continued use could contribute to antimicrobial resistance and increase the risk of adverse reactions such as nausea, vomiting, diarrhoea, stomach discomfort and skin rashes.
NAFDAC directed its zonal directors and state coordinators to begin surveillance and mop-up operations to remove the affected batch from circulation nationwide.
It also instructed distributors, wholesalers, retailers, pharmacies, hospitals and other healthcare facilities to immediately stop selling or distributing the product, while members of the public in possession of the recalled batch have been advised to quarantine it and discontinue its use pending the completion of the recall.
