NAFDAC alerts public to recall of Sporidex suspension batch over impurity concerns

NAFDAC alerts public to recall of Sporidex suspension batch over impurity concerns

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 discomfort, and skin rash. NAFDAC advised healthcare professionals and the public to
avoid the distribution or use of 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 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 via the online reporting platforms on the
NAFDAC website (www.nafdac.gov.ng), 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.

Source: NAFDAC alerts public to recall of Sporidex suspension batch over impurity concerns

 - NigerianEye
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