PHOENIX (KSAZ) -- Officials with Tris Pharma, Inc. announced Wednesday a voluntary recall of three lots of infant ibuprofen, due to a potentially higher concentration of ibuprofen.
According to the statement, the lots ian infant ibuprofen oral suspension that were used as a pain reliever/fever reducer. They were packaged in 0.5oz bottles for three products Infants' Ibuprofen Concentrated Oral Suspension that were sold by Walmart, CVS, and Family Dollar.
Officials say there is a "remote possibility" that the infants, who may be more susceptible to a higher drug potency level, may be more vulnerable to permanent NSAID-associated renal injuries, as well as other adverse effects including nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache and gastrointestinal bleeding.
Tris Pharma officials said they have not received any reports of adverse events related to the product lots that are subjected to the recall. Customers with questions on the recall can call Tris Pharma at (732) 940-0358, from 8:00 a.m. Eastern Time to 5:00 p.m. Pacific Time, Monday through Friday or by customer service e-mail.