NAFDAC recalls Sporidex Suspension drug, warns of potential safety r!sk for children
NAFDAC recalls Sporidex Suspension drug, warns of potential safety risk for children
The National Agency for Food and Drug Administration and Control (NAFDAC) has recalled a batch of Sporidex Suspension, a commonly prescribed antibiotic for children, after an impurity was found to exceed approved safety limits.
The affected product is Sporidex Suspension 125 mg/5 ml, batch number DFG4606A, which is marketed in Nigeria by Ranbaxy Nigeria Ltd, a Sun Pharma company.
In a public alert issued on Thursday, NAFDAC said the company voluntarily initiated the recall after quality checks detected an impurity above the acceptable specification.
According to the agency, the impurity could compromise the medicine’s quality, safety and stability, making it less effective in treating bacterial infections.
Sporidex Suspension contains cephalexin, an antibiotic widely prescribed for children to treat infections of the throat, ears, skin, bones, teeth, urinary tract and kidneys.
NAFDAC warned that children who use the affected batch may not receive the full therapeutic benefit of the medicine, which could result in delayed recovery, worsening infections or treatment failure.
The agency also cautioned that reduced effectiveness of antibiotics can contribute to antimicrobial resistance, a growing public health concern where bacteria become resistant to available treatments.
In addition, users of the affected batch may experience side effects such as nausea, vomiting, diarrhoea, stomach discomfort and skin rashes, the regulator said.
To prevent further circulation of the product, NAFDAC directed all its zonal directors and state coordinators to begin surveillance and remove the affected batch from the Nigerian market.
“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,” the agency said.
The regulator also instructed distributors, wholesalers, retailers, pharmacies, hospitals and other healthcare providers to immediately stop selling or distributing the affected batch.
Consumers who have the recalled medicine at home have been advised not to use it. Instead, they should isolate the product and return it to the pharmacy, hospital or healthcare facility where it was obtained.
The recall applies only to batch number DFG4606A and does not automatically affect other batches of Sporidex Suspension.
Parents and caregivers are encouraged to check the batch number on the medicine label before administering the antibiotic to children and seek medical advice if they have concerns about any treatment already given.
