Tris Pharma has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to have potentially higher concentrations of ibuprofen.
There is a possibility that infants may be more vulnerable to permanent NSAID-associated renal injury if they are more susceptible to a higher potency level of drug. Adverse effects may be nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. Tris Pharma has not received any reports of illnesses related to the recall.
Infants' Ibuprofen Concentrated Oral Suspension is used as a pain reliever/fever reducer and was packaged in 0.5 oz bottles. The product was sold in Walmart, CVS and Family Dollar stores and contain the lots: 00717009A, 00717015A, 00717024A, 00717024A, 00717024A.
Wholesalers and retailers should pull the affected lots off shelves.
