*The National Agency for Food and Drug Administration and Control discloses the Sporidex Suspension 125 mg/5 mL with Batch No. DFG4606A has shown an impurity exceeding safe specification limits that compromises product quality, safety, and stability, urging affected consumers to immediately stop giving, or taking this specific batch
Isola Moses | ConsumerConnect
In furtherance of its customer-focused, agency-minded approach to safeguarding the health of Nigerian consumers, the National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert to healthcare providers and the general public of the voluntary nationwide recall of Sporidex Suspension 125 mg/5 mL (Batch No. DFG4606A) due to an impurity detected above approved safety limits.
ConsumerConnect reports NAFDAC, in a recent public alert, said the affected pharmaceutical product that contains cephalexin with Batch Number: DFG4606A was manufactured by Ranbaxy Nigeria Limited, a Sun Pharma Company.
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The health sector regulatory agency also disclosed the Sporidex Suspension 125 mg/5 mL showed an impurity exceeding safe specification limits that compromises product quality, safety, and stability.
What about Sporidex Suspension 125 mg/5 ml?
NAFDAC has described the Sporidex Suspension 125 mg/5 ml as a cephalosporin antibiotic medicine that contains cephalexin.
The agency explained that it is used in children to treat bacterial infections affecting the throat, ears, skin, bone, teeth, urinary bladder, and kidneys.
Product details at a glance
The details of the recalled product are as follows;
- Product Name: Sporidex Suspension 125 mg/5 mL
- Product Manufacturer: Ranbaxy Nigeria Limited (Sun Pharma Company)
- Batch Number: DFG4606A
Risk statement
According to the health sector regulator, 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.
The agency further noted that there may be an increased risk of adverse reactions, including nausea, vomiting, diarrhoea, stomach discomfort, and skin rash.
The agency, therefore, urged consumers to immediately stop giving or taking this specific batch.
It equally urged wholesalers and retailers to stop selling or distributing it by returning the affected product to a store or pharmacy of purchase
Affected consumers are also urged to send any side effects, or complaints to NAFDAC via e-mail at pharmacovigilance@nafdac.gov.ng or use the Med Safety app.
NAFDAC, therefore, advised the public and healthcare professionals to exercise caution, and avoid the use or distribution of the affected batch pending completion of the recall process from marketplaces.
It also directed all Zonal Directors and State Coordinators 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 halt the distribution and sale of the affected batch in the country.
Besides, NAFDAC charged all persons in possession of the affected product batch to quarantine it and discontinue further supply.
The agency as well urged consumers and caregivers, who have the affected batch to not use the product, but 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 Web site 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, consumers are directed to call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng