Infant ibuprofen destined to be soldat several national retailers might contain ahigherconcentrationof ibuprofen, leading to potential risks in infants, according to a Wednesday voluntary recall notice.
New Jersey-based Tris Pharma Inc.said lots sold under Walmart, CVS Pharmacyand Family Dollar brands are impacted by the recall.The products were labeled to contain50 mg of Ibuprofenper 1.25 mL.
The company said there is a“remote possibility” the increased amount ofibuprofen could lead topermanent kidney injury in infants.Other adverse effects could include nausea, vomiting, stomach pain and diarrhea, along with tinnitus, headaches or possible stomach bleeding.
To date, the company says it has not received any reports of adverse events related to the recall.
Tris Pharma saysthe affected lots of ibuprofen were sold to a customer that distributes the drug to retailers. Retailers and wholesalers of the product have been told to stop further distribution of the effected lots.
Intended for use as a pain reliever and fever reducer, the product was packaged in 0.5 oz. bottles and labeled “Infants’ Ibuprofen Concentrated Oral Suspension.”
Walmart sells the product under the“Equate” label; CVS sells it under the “CVS Health” label and Family Dollar sells it under the “Family Wellness” label.
The releasedoes not specify which states received the product.
The impactedproducts bear lot numbers00717009A,00717015A,00717024A from Walmart;00717024A from CVS; and00717024A from Family Dollar.
The packages are labeled with NDC (National Drug Code) numbers of49035-125-23 from Walmart,59779-925-23 from CVSand55319-250-23 from Family Dollar.
More information about the recall is available from the company’s release.