The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare providers, importers, distributors, and caregivers about the recall of around 90,000 bottles of Children’s Ibuprofen Oral Suspension in the US due to safety concerns.
In a public alert released on Saturday, NAFDAC said it got information that the United States Food and Drug Administration announced the recall after people reported finding foreign material in the product.
NAFDAC explained that the recall started by Strides Pharma Inc. after consumers reported seeing a “gel-like mass” and “black particles” in the oral suspension.
Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is usually given to relieve pain from common colds, flu, sore throat, headache, and toothaches in children. It is also used to help reduce fever.
Health risks
NAFDAC warned that foreign material in medicines can affect their quality, safety, and effectiveness.
The agency noted that giving contaminated oral suspensions could lead to bad reactions, especially among children. It could also cause choking or stomach issues depending on the kind of contaminant.
Affected products
The product that is being recalled is Children’s Ibuprofen Oral Suspension, USP, 100 mg/5 mL, which comes in 120 mL (4 fl. oz.) bottles.
This product was made by Strides Pharma Inc. in India for Taro Pharmaceuticals U.S.A., Inc.
NAFDAC mentioned that the affected batches have lot numbers 7261973A and 7261974A, and they expire on 31 January 2027.
The recalled products were sent out across the US.
Surveillance in Nigeria
Even though the affected products were only distributed and recalled in the US, NAFDAC said it is taking steps to keep them out of Nigeria through both legal and illegal channels.
The agency has told all its zonal directors and state coordinators to increase surveillance and remove these products if they find them in their areas.
“NAFDAC remains committed to protecting public health and will keep up surveillance to ensure the quality, safety, and effectiveness of medicines in Nigeria,” the agency stated.
Advice to healthcare providers, parents
NAFDAC advised importers, distributors, retailers, and healthcare professionals to be alert and make sure that medical products come only from authorized and licensed suppliers.
The agency also urged healthcare facilities to check their stocks and quarantine any affected batches if found.
Parents and caregivers who have these recalled products or have given them to children are urged to stop using them right away and seek medical help if they notice any unusual reactions.
NAFDAC encouraged healthcare professionals and the public to report any bad reactions linked to medicines through its pharmacovigilance channels. These include its e-reporting platform and the Med Safety mobile app.
Reports can also be sent through the nearest NAFDAC office or via its dedicated pharmacovigilance email address.
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