The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians against children’s ibuprofen oral suspension, which was recalled in the United States.
In a post on X, NAFDAC said it received notification that the United States Food and Drug Administration had announced the recall of approximately 90,000 bottles of the drug due to the presence of foreign material in the product.
NAFDAC said that Strides Pharma Inc initiated the recall after consumers complained of a “gel-like mass” and “black particles” in the oral suspension.
The agency said that the product was manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals USA Inc.
NAFDAC said the affected batches are lot numbers 7261973A and 7261974A, with an expiry date of January 31, 2027.
The agency cautioned that the presence of foreign material in medicinal products could compromise their quality, safety, and effectiveness.
NAFDAC said administering contaminated oral suspensions may result in adverse reactions among children, and could pose choking or gastrointestinal risks depending on the nature of the contaminant.
The affected product is children’s ibuprofen oral suspension, USP, 100 mg/5 ml, packaged in 120 mL (4 fl. oz.) bottles, and were distributed nationwide in the US.
NAFDAC said although the affected products were distributed and recalled within the US, 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.
NAFDAC, however, urged importers, distributors, retailers, and healthcare professionals to remain vigilant and ensure that medical products are sourced only from authorised and licensed suppliers.
The agency noted that healthcare facilities should immediately inspect their inventories and quarantine any affected batches if identified.
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