NAFDAC issues safety alert on 90,000 bottles of US children’s Ibuprofen recall

Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has issued a safety alert regarding the recall of approximately 90,000 bottles of Children's Ibuprofen Oral Suspension in the United States. The U.S. Food and Drug Administration initiated the recall after consumers reported finding a "gel-like mass" and "black particles" within the medication.

The affected product, Children's Ibuprofen Oral Suspension, USP (100 mg/5 mL), is a common pain reliever for children. Strides Pharma Inc., the manufacturer, recalled the product after the foreign material was discovered. The recalled batches, lot numbers 7261973A and 7261974A, have an expiry date of January 31, 2027, and were distributed within the U.S.

NAFDAC emphasized that foreign materials in medicinal products can compromise their quality, safety, and effectiveness. Although the recall was limited to the U.S., the agency is implementing proactive measures to prevent any affected products from reaching the Nigerian market. All NAFDAC zonal directors and state coordinators have been instructed to intensify surveillance and remove any identified affected products.

The regulatory body advised importers, distributors, retailers, healthcare professionals, and caregivers to remain vigilant. They are urged to avoid the importation, sale, distribution, or use of the recalled products. Healthcare facilities should immediately inspect their inventories and quarantine any identified affected batches. Parents and caregivers with the affected products should discontinue use and seek medical attention if any unusual reactions are observed in children.

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They should seek medical attention if any unusual reactions are observed in children who may have taken the medication.