Healthcare professionals, importers, distributors, and caregivers have been informed by the National Agency for Food and Drug Administration and Control (NAFDAC) of the recall of over 90,000 bottles of Children's Ibuprofen Oral Suspension in the United States owing to contamination concerns. The US Food and Drug Administration initiated the recall in response to concerns of foreign material in the product, the agency stated in a public advisory released on Saturday. Strides Pharma Inc. initiated the recall, according to NAFDAC, after customers reported "black particles" and a "gel-like mass" in the oral solution. Children's Ibuprofen Oral Suspension, USP (100 mg/5 mL), is frequently used to reduce fever and ease discomfort from the flu, common cold, sore throat, headache, and toothache.
NAFDAC cautioned that the quality, safety, and efficacy of pharmaceuticals could be jeopardized by the presence of alien substances. According to the government, depending on the type of contamination, giving contaminated oral suspensions could cause gastrointestinal or choking hazards as well as negative reactions, especially in children.
Children's Ibuprofen Oral Suspension, USP, 100 mg/5 mL, in 120 mL (4 fl. oz.) bottles, is the product in question. According to NAFDAC, the impacted batches are lot numbers 7261973A and 7261974A, with an expiration date of January 31, 2027. The product was produced in India by Strides Pharma Inc. for Taro Pharmaceuticals U.S.A., Inc. In the US, the recalled goods were sold all across the country.
NAFDAC stated that it is taking preventative measures to stop the impacted products from entering Nigeria through authorized or unauthorized channels, even if they were distributed and recalled in the United States. According to the agency, all of its state coordinators and zonal directors have been instructed to step up surveillance efforts and take the items out of circulation if they are discovered inside their respective jurisdictions.
NAFDAC urged importers, distributors, retailers, and medical professionals to exercise caution and make sure that only authorized and licensed providers provide medicinal supplies.
Additionally, the FDA advised healthcare providers to check their inventory right away and quarantine any batches that were found to be impacted. It was recommended that parents and caregivers who have the recalled goods or who may have given them to children cease using them immediately and seek medical help if any strange reactions are noticed.
Through its pharmacovigilance channels, including its e-reporting portal and the Med Safety mobile application, NAFDAC also urged medical professionals and the general public to report adverse reactions related to pharmaceutical goods. The organization stated that reports could also be sent via its authorized pharmacovigilance email address or the closest NAFDAC office.
