The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of a specific batch of Sporidex Suspension 125 mg/5 ml after an impurity exceeding approved safety limits was detected in the product.
According to a statement issued on Thursday, the affected product is batch number DFG4606A of Sporidex Suspension 125 mg/5 ml, an antibiotic containing cephalexin commonly prescribed for children to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary tract and kidneys.
NAFDAC said the voluntary recall was initiated by Ranbaxy Nigeria Ltd, a Sun Pharma company and the drug’s marketing authorisation holder, after quality checks revealed an impurity above acceptable specifications.
The agency warned that the impurity could compromise the quality, safety and stability of the medicine.
According to NAFDAC, using the affected batch may reduce the effectiveness of the antibiotic, leading to incomplete treatment of bacterial infections, delayed recovery, worsening illness or treatment failure.
The agency also warned that reduced effectiveness could contribute to antimicrobial resistance, while users may face an increased risk of side effects such as nausea, vomiting, diarrhoea, stomach discomfort and skin rash.
“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.
The agency instructed distributors, wholesalers, retailers, pharmacies, hospitals and other healthcare providers to immediately stop distributing or selling the affected batch.
NAFDAC also advised members of the public who have the product to quarantine it, stop using or supplying it, and return it to where it was purchased or the nearest healthcare facility.
Patients and healthcare professionals were encouraged to report any adverse reactions or side effects through the reporting platforms available on the NAFDAC website, the Med Safety mobile application, or via the agency’s official reporting channels.
The recall forms part of NAFDAC’s efforts to ensure that only safe, effective and quality medicines remain available to Nigerians.
