The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public safety alert following the recall of about 90,000 bottles of children’s Ibuprofen oral suspension in the United States over contamination concerns.
The affected product, commonly used to relieve fever, pain, sore throat, headaches and flu-related discomfort in children, was withdrawn after the United States Food and Drug Administration (United States Food and Drug Administration) confirmed reports of foreign materials found in some batches.
According to U.S. regulators and the manufacturer, Strides Pharma (Strides Pharma), consumers reported the presence of a “gel-like mass” and black particles in the medication, prompting an immediate voluntary recall.
The product, Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is manufactured by Strides Pharma in India for Taro Pharmaceuticals (Taro Pharmaceuticals) and distributed in the United States in 120 mL bottles.
NAFDAC said the development raises serious concerns about product quality and patient safety, warning that the presence of foreign materials in medicines could compromise their effectiveness and pose health risks, especially to children.
The affected batches are identified as lot numbers 7261973A and 7261974A, with an expiry date of January 31, 2027.
Although the recall was carried out in the United States, the Nigerian drug regulator said it is taking proactive steps to ensure the products do not enter the Nigerian market.
NAFDAC disclosed that all zonal directors and state coordinators have been directed to intensify surveillance across pharmaceutical outlets, import channels and distribution networks nationwide.
It also urged importers, distributors, healthcare providers and pharmacy operators to remain vigilant and avoid the importation, sale or circulation of the affected batches.
Parents and caregivers were further advised to discontinue use of any product matching the description and batch numbers, while those who notice unusual reactions in children are encouraged to seek immediate medical attention.
The agency added that healthcare facilities should urgently review their inventories and quarantine any suspected products pending further instructions.
NAFDAC reaffirmed its commitment to safeguarding public health, stating that it will continue to monitor global drug safety alerts and take necessary actions to protect Nigerians from substandard or unsafe medicines.
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