The National Agency for Food and Drug Administration and Control, NAFDAC, has alerted Nigerians to the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States.
The product was recalled by the United States Food and Drug Administration due to the presence of foreign material inside the medication.
According to NAFDAC, the recall was initiated by Strides Pharma Inc. the product manufacturers after consumers reported the presence of a “gel-like mass” and “black particles” in the oral suspension.
The product, Children’s Ibuprofen Oral Suspension, USP, 100 mg/5 mL, is commonly used to relieve pain associated with colds, flu, sore throat, headaches and toothaches in children.
NAFDAC warned that the presence of foreign materials in medicinal products could compromise their quality, safety and effectiveness.
The affected products are packaged in four-fluidounce,120 mL, bottles and were manufactured by Strides Pharma Inc., India, for Taro Pharmaceuticals in the U.S.
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Lot numbers of the recalled batches are 7261973A and 7261974A, with an expiry date of Jan. 31, 2027. Although the medication was distributed and recalled within the U.S., NAFDAC said it was taking proactive measures to prevent them from entering the Nigerian market.
It said all zonal directors and state coordinators had been directed to intensify surveillance activities and remove any affected products found within their jurisdictions.
The regulatory body advised importers, distributors, retailers, healthcare professionals and caregivers to remain vigilant and avoid the importation, sale, distribution or use of the recalled products.
It also urged healthcare facilities to inspect their inventories immediately and quarantine any affected batches identified.
The agency advised parents and caregivers in possession of the affected products to discontinue use. “They should seek medical attention if any unusual reactions are observed in children who may have taken the medication,” NAFDAC said.
Healthcare professionals and members of the public are also encouraged to report adverse events associated with medicinal products through its reporting platforms or the nearest NAFDAC office.
NAFDAC reaffirmed its commitment to safeguarding public health through continuous monitoring of medicines circulating in the country.
NAN
