The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers and the public of the voluntary recall of Sporidex Suspension 125 mg/5 mL, Batch No. DFG4606A.
The Marketing Authorization Holder, Ranbaxy Nigeria Ltd. (a Sun Pharma Company), initiated a recall as a precautionary measure after detecting an impurity exceeding the approved specification limit. The presence of this impurity may compromise the quality, safety, and stability of the product.
Sporidex Suspension 125 mg/5 ml is a cephalosporin antibiotic medicine that contains cephalexin. It is used in children to treat bacterial infections affecting the throat, ears, skin, bone, teeth, urinary bladder, and kidneys.
Risk Statement
Potential risks associated with the use of the affected product include reduced antibiotic effectiveness, which may result in incomplete bacterial eradication, delayed recovery, worsening infection, or treatment failure. It may also contribute to the development of antimicrobial resistance.
There may also be an increased risk of adverse reactions, including nausea, vomiting, diarrhoea, stomach discomfort, and skin rash.
Product Details
The details of the recalled product are as follows;
Product Name: Sporidex Suspension 125 mg/5 mL
Product Manufacturer: Ranbaxy Nigeria Ltd. (Sun Pharma Company)
Batch Number: DFG4606A
NAFDAC advises the public and healthcare professionals to exercise caution and avoid the use or distribution of the affected batch pending 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.
Distributors, wholesalers, retailers, pharmacies, hospitals, and other healthcare facilities should immediately cease the distribution and sale of the affected batch.
All persons in possession of the affected batch should quarantine the product and discontinue further supply.
Consumers and caregivers who have the affected batch are advised not to use the product and to return it to the point of purchase or the nearest healthcare facility.
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
