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 over concerns about an impurity found in the product.
Sporidex suspension is an antibiotic containing cephalexin and is commonly prescribed for children to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary bladder and kidneys.
In a statement issued on Thursday, July 23, NAFDAC said Ranbaxy Nigeria Ltd, a Sun Pharmaceutical company and the marketing authorisation holder of the drug, initiated the voluntary recall after detecting an impurity that exceeded approved specifications.
The agency said the presence of the impurity could compromise the quality, safety and stability of the product.
According to NAFDAC, use of the affected batch could reduce the effectiveness of the antibiotic, potentially resulting in incomplete eradication of bacteria, delayed recovery, worsening infections or treatment failure.
The agency added that sub-optimal efficacy could contribute to antimicrobial resistance and increase the risk of side effects, including nausea, vomiting, diarrhoea, stomach discomfort and skin rash.
NAFDAC advised healthcare professionals, distributors and members of the public to stop the distribution, sale and use of the affected batch pending the completion of the recall process.
The agency said its zonal directors and state coordinators had been directed to conduct surveillance and mop-up operations to identify and remove the recalled product from circulation across Nigeria.
It also directed distributors, wholesalers, retailers, pharmacies, hospitals and other healthcare facilities to immediately cease the distribution and sale of sporidex suspension 125 mg/5 ml, batch number DFG4606A.
Individuals who have the affected product were advised to quarantine it, discontinue its supply and return it to the point of purchase or the nearest healthcare facility.
NAFDAC also urged patients and healthcare providers to report any adverse events or side effects associated with the product through its online reporting platforms, the med-safety mobile application or its email channel.
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