The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a 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 statement issued on Thursday, NAFDAC said Ranbaxy Nigeria Ltd, a Sun Pharma company and 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 quality, safety, and stability of the product.
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 sub-optimal efficacy could also contribute to antimicrobial resistance, alongside an increased risk of side effects such as nausea, vomiting, diarrhea, stomach
