The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, importers, distributors and caregivers to the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the US due to contamination concerns.
In a public alert issued on Saturday, the agency said it received notification that the United States Food and Drug Administration had announced the recall following reports of foreign material in the product.
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According to NAFDAC, the recall was initiated by Strides Pharma Inc. after consumers complained of a “gel-like mass” and “black particles” in the oral suspension.
Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is commonly used to relieve pain associated with the common cold, flu, sore throat, headache and toothache in children, and to reduce fever.
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Health risks
NAFDAC warned that the presence of foreign material in medicinal products could compromise their quality, safety and effectiveness.
The agency noted that administering contaminated oral suspensions may result in adverse reactions, particularly among children, and could pose choking or gastrointestinal risks depending on the nature of the contaminant.
Affected products
The affected product is Children’s Ibuprofen Oral Suspension, USP, 100 mg/5 mL, packaged in 120 mL (4 fl. oz.) bottles.
The product was manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals U.S.A., Inc.
NAFDAC said the affected batches are lot numbers 7261973A and 7261974A, with an expiry date of 31 January 2027.
The recalled products were distributed nationwide in the US.
Surveillance in Nigeria
Although the affected products were distributed and recalled within the US, NAFDAC said it is taking precautionary measures to prevent them from entering Nigeria through authorised or unauthorised channels.
The agency said it had directed all its zonal directors and state coordinators to intensify surveillance activities and remove the products from circulation if found in their jurisdictions.
“NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety and efficacy of medicines circulating in Nigeria,” the agency said.
Advice to healthcare providers, parents
NAFDAC advised importers, distributors, retailers and healthcare professionals to remain vigilant and ensure that medical products are sourced only from authorised and licensed suppliers.
The agency also urged healthcare facilities to immediately inspect their inventories and quarantine any affected batches if identified.
Parents and caregivers who possess the recalled products, or who may have administered them to children, were advised to stop using them immediately and seek medical attention if any unusual reactions are observed.
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NAFDAC further encouraged healthcare professionals and members of the public to report adverse reactions associated with medicinal products through its pharmacovigilance channels, including its e-reporting platform and the Med Safety mobile application.
The agency said reports could also be submitted through the nearest NAFDAC office or via its designated pharmacovigilance email address.
