Tris Pharma issued a voluntary recall notice on Wednesday for Infants' Ibuprofen Concentrated Oral Suspension due to products that have been found to potentially have higher concentrations of ibuprofen.
The recall states that some infants who may be more susceptible to a higher potency level of drug may be more vulnerable to permanent NSAID-associated renal injury.
The recall says that nausea, vomiting, epigastric pain, or more rarely, diarrhea are possible adverse effects. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects, the recall says.
The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles.
For more information on the recall, click here.