Tris Pharma Inc. voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP 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 than normal.
“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID [nonsteroidal anti-inflammatory drug]–associated renal