The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of batch number DFG4606A of Sporidex Suspension 125 mg/5 ml.
Sporidex Suspension is an antibiotic containing cephalexin, commonly prescribed for children to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary bladder, and kidneys.
In a recent statement, NAFDAC said Ranbaxy Nigeria Ltd, a Sun Pharma company and the marketing authorisation holder of the drug, initiated the voluntary recall after detecting an impurity that exceeded approved specifications.
The agency noted that the presence of the impurity compromises the product’s quality, safety, and stability.
According to the statement, using the affected batch poses risks, including reduced antibiotic effectiveness, which could lead to incomplete bacterial eradication, delayed recovery, worsening infection, or treatment failure.
It added that suboptimal efficacy could also contribute to antimicrobial resistance, alongside an increased risk of side effects such as nausea, vomiting, diarrhoea, stomach discomfort, and skin rash.
NAFDAC advised healthcare professionals and the public to avoid distributing or using the affected batch pending the completion of the recall process.
“All zonal directors and state coordinators have been directed to conduct surveillance and mop-up activities to identify and remove any recalled Sporidex Suspension 125 mg/5 ml (Batch No. DFG4606A) from circulation in Nigeria,” NAFDAC said.
“Distributors, wholesalers, retailers, pharmacies, hospitals, and other healthcare facilities should immediately cease the distribution and sale of the affected batch.”
The agency urged individuals in possession of the affected product to quarantine it, discontinue its supply, and return it to the point of purchase or the nearest healthcare facility.
Patients and healthcare providers were also encouraged to report adverse events or side effects through the online reporting platforms on the NAFDAC website, the Med Safety mobile application, or by email at pharmacovigilance@nafdac.gov.ng.
Complaints can also be lodged with the NAFDAC Reforms Unit via 09097630506, 09097630507, or reforms@nafdac.gov.ng.
